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1. Physical Activity Together for People With Multiple Sclerosis and Their Care Partners: Protocol for a Feasibility Randomized Controlled Trial of a Dyadic Intervention

Author

Fakolade, Afolasade, Cameron, Julie, McKenna, Odessa, Finlayson, Marcia L, Freedman, Mark S, Latimer-Cheung, Amy E, and Pilutti, Lara A

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundPhysical activity (PA) is beneficial for all people; however, people affected by multiple sclerosis (MS) find regular PA challenging. These people may include individuals with advanced disabilities and their care partners. ObjectiveThe objective of this study is to determine the feasibility of a dyadic PA intervention for people with advanced MS and their care partners. MethodsThis study is a randomized controlled feasibility trial of a 12-week intervention, with 1:1 allocation into an immediate intervention condition or delayed control condition. A target of 20 people with MS–care partner dyads will be included. The outcomes will be indicators of process, resources, management, and scientific feasibility. Participant satisfaction with the intervention components will be evaluated using a satisfaction survey. The subjective experience of participation in the study will be explored using semistructured interviews. ResultsThe project is funded by the Consortium of Multiple Sclerosis Centers. This protocol was approved by the Ottawa Hospital Research Ethics Board (20190329-01H) and the University of Ottawa Research Ethics Board (H-09-19-4886). The study protocol was registered with ClinicalTrials.gov in February 2020. The findings of this feasibility trial will be disseminated through presentations at community events to engage the MS population in the interpretation of our results and in the next steps. The results will also be published in peer-reviewed journals and presented to the scientific community at national and international MS conferences. ConclusionsThe data collected from this feasibility trial will be used to refine the intervention and materials in preparation for a pilot randomized controlled trial. Trial RegistrationClinicalTrials.gov NCT04267185; https://clinicaltrials.gov/ct2/show/NCT04267185. International Registered Report Identifier (IRRID)PRR1-10.2196/18410

Published
2021
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2. A Physician-Completed Digital Tool for Evaluating Disease Progression (Multiple Sclerosis Progression Discussion Tool): Validation Study

Author

Ziemssen, Tjalf, Piani-Meier, Daniela, Bennett, Bryan, Johnson, Chloe, Tinsley, Katie, Trigg, Andrew, Hach, Thomas, Dahlke, Frank, Tomic, Davorka, Tolley, Chloe, and Freedman, Mark S

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
Abstract

BackgroundDefining the transition from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive multiple sclerosis (SPMS) can be challenging and delayed. A digital tool (MSProDiscuss) was developed to facilitate physician-patient discussion in evaluating early, subtle signs of multiple sclerosis (MS) disease progression representing this transition. ObjectiveThis study aimed to determine cut-off values and corresponding sensitivity and specificity for predefined scoring algorithms, with or without including Expanded Disability Status Scale (EDSS) scores, to differentiate between RRMS and SPMS patients and to evaluate psychometric properties. MethodsExperienced neurologists completed the tool for patients with confirmed RRMS or SPMS and those suspected to be transitioning to SPMS. In addition to age and EDSS score, each patient’s current disease status (disease activity, symptoms, and its impacts on daily life) was collected while completing the draft tool. Receiver operating characteristic (ROC) curves determined optimal cut-off values (sensitivity and specificity) for the classification of RRMS and SPMS. ResultsTwenty neurologists completed the draft tool for 198 patients. Mean scores for patients with RRMS (n=89), transitioning to SPMS (n=47), and SPMS (n=62) were 38.1 (SD 12.5), 55.2 (SD 11.1), and 69.6 (SD 12.0), respectively (P

Published
2020
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3. Sphingosine 1-phosphate receptor modulators in multiple sclerosis treatment: A practical review.

Author

Coyle, Patricia, Freedman, Mark, Cohen, Bruce, Cree, Bruce, and Markowitz, Clyde

Subjects
United States, Humans, Multiple Sclerosis, Sphingosine 1 Phosphate Receptor Modulators, Sphingosine-1-Phosphate Receptors, Fingolimod Hydrochloride, Administration, Oral
Abstract

Four sphingosine 1-phosphate (S1P) receptor modulators (fingolimod, ozanimod, ponesimod, and siponimod) are approved by the US Food and Drug Administration for the treatment of multiple sclerosis. This review summarizes efficacy and safety data on these S1P receptor modulators, with an emphasis on similarities and differences. Efficacy data from the pivotal clinical trials are generally similar for the four agents. However, because no head-to-head clinical studies were conducted, direct efficacy comparisons cannot be made. Based on the adverse event profile of S1P receptor modulators, continued and regular monitoring of patients during treatment will be instructive. Notably, the authors recommend paying attention to the cardiac monitoring guidelines for these drugs, and when indicated screening for macular edema and cutaneous malignancies before starting treatment. To obtain the best outcome, clinicians should choose the drug based on disease type, history, and concomitant medications for each patient. Real-world data should help to determine whether there are meaningful differences in efficacy or side effects between these agents.

Published
2024

8. Neurofilaments as biomarkers in neurological disorders — towards clinical application

Author

Khalil, Michael, Teunissen, Charlotte E., Lehmann, Sylvain, Otto, Markus, Piehl, Fredrik, Ziemssen, Tjalf, Bittner, Stefan, Sormani, Maria Pia, Gattringer, Thomas, Abu-Rumeileh, Samir, Thebault, Simon, Abdelhak, Ahmed, Green, Ari, Benkert, Pascal, Kappos, Ludwig, Comabella, Manuel, Tumani, Hayrettin, Freedman, Mark S., Petzold, Axel, Blennow, Kaj, Zetterberg, Henrik, Leppert, David, and Kuhle, Jens

Published
2024
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10. Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials

Author

Carra, Adriana Josefa, Deri, Norma Haydee, Jose, Jorge Gustavo, del Valle Liwacki, Susana, Mainella, Carolina Natalia, Pagani, Fatima, Povedano, Guillermo, Alfici, Alberto Rodriguez, Tavolini, Dario Raul, Buonanotte, Carlos Federico, Burgos, Marcos, Giugni, Juan Carlos, Artesi, Juan Jose Martin, Rojas, Juan Ignacio, Zuin, Daniel Raul, Videla, Hugo Osvaldo, Correale, Jorge Daniel, Luetic, Geraldine G., Hodgkinson, Suzanne, Lechner-Scott, Jeannette, Parratt, John, Saines, Noel, Reddel, Stephen, Wijeratne, Tissa, Taylor, Bruce, Deisenhammer, Florian, Traxler, Gerhard, Leutmezer, Fritz, Wipfler, Peter, Weber, Joerg R., Lampl, Christian, Bartholome, Emmanuel, Dive, Dominique, Glibert, Nele, Perrotta, Gaetano, Pesch, Vincent, Buyle, Maarten, Wijmeersch, Bart, Willekens, Barbara, Basagic, Edin, Mehmedika Suljic, Enra, Klupka-Sarić, Inge, Danovska, Maya, Dimitrova, Maria, Genov, Krasimir, Izmaylov, Alim, Mavrov, Radoslav, Milanov, Ivan, Naydenov, Valcho, Shotekov, Penko, Tarnev, Ivaylo, Traykov, Latchezar, Emond, Francois, Selchen, Daniel, Rivest, Donald, Sabella, Lisa, Witkowski, Ludivine, Saveriano, Alexander, Bolano Solano, Addinson Rene, Ruiz, Cesar Augusto Franco, Nassar Tobon, Andrea Catalina, Cardozo, Carlos Alberto Navas, Schlesenger, Antonio, Triana, Javier Dario, Sarabia, Osvaldo Elias Lara, Montero, Luis Alfonso Zarco, Arango, Jorge Andres Jimenez, Basic, Silvio, Pasic, Marija Bosnjak, Soldo, Silva Butkovic, Habek, Mario, Kidjemet-Piskac, Spomenka, Matijaca, Meri, Vuletic, Vladimira, Ampapa, Radek, Dufek, Michal, Grunermelova, Marketa, Mares, Jan, Martinkova, Alena, Peterka, Marek, Stetkarova, Ivana, Stourac, Pavel, Talab, Radomir, Tyblova, Michaela, Marta, Vachova, Valis, Martin, Hradilek, Pavel, Rockova, Petra, Gross-Paju, Katrin, Haldre, Sulev, Airas, Laura, Karppa, Mikko, Bourre, Bertrand, Casez, Olivier, Ciron, Jonathan, Kwitakowski, Arnaud, Labauge, Pierre, Lebrun Frenay, Christine, Michel, Laure, Derache, Nathalie, Vukusic, Sandra, Laplaud, David-Axel, Beridze, Maia, Chakhava, George, Gauarashvili, Ann, Giorgadze, Gvantsa, Guldedava, Nana, Janelidze, Marina, Kiziria, Marina, Shakarishvili, Roman, Tsiskaridze, Alexander, Chkhikvishvili, Shalva, Albert, Christian, Berthele, Achim, Yalachkov, Yavor, Pitarokoili, Kalliopi, Kallmann, Boris-Alexander, Klotz, Luisa, Oschmann, Patrick, Pul, Refik, Rau, Daniela, Skripuletz, Thomas, Chan, Koon Ho, Lau, Alexander Yuk Lun, Li, Jessica Tsz Ching, Wong, Wa Tai, Maria, Biro Zita, Bokor, Magdolna, Dobos, Eniko, Janszky, Jozsef, Kovacs, Krisztina, Lazarcsik, Ildiko, Piros, Palma, Rozsa, Csilla, Satori, Maria, Simo, Magdolna, Nagy, Ferenc, Behari, Madhuri, Kulkarni, Rahul, Kumar, Radhakrishanan Suresh, Dwivedee, Shamsher, Iype, Thomas, Baviskar, Rahul, Mathukumalli, Neeharika L., Gilad, Ronit, Karussis, Dimitrios, Milo, Ron, Shahien, Radi, Vaknin, Adi, Weller, Boaz, Wilf-Yarkoni, Adi, Achiron, Anat, Aguglia, Umberto, Di Gregorio, Maria, Calabrese, Massimiliano, Cordioli, Cinzia, Sessa, Edoardo, Tomassini, Valentina, Inglese, Matilde, Castro Farfan, Freddy Guillermo, Roldan, Giovana Femat, Gonzalez Guardado, Antonio, Lopez Meza, Elmer, Maldonado, Jair Fernando, Boschetti, Laura Ordonez, Partida Medina, Luis Roberto, Frequin, Stephan, Hupperts, Raymond, Schrijver, Hans, Smolders, Joost, Diaz, Cesar Abel Castaneda, Pretell, Edwin, Boczarska-Jedynak, Magdalena, Bonek, Robert, Brola, Waldemar, Darda-Ledzion, Lidia, Fryze, Waldemar, Maciejowski, Maciej, Rejdak, Konrad, Rosciszewska-Zukowska, Iwona, Selmaj, Krzysztof, Szymanska, Malgorzata, Zajda, Małgorzata, Zielinski, Tomasz, Beata, Zakrzewska-Pniewska, Adam, Stepien, Swiat, Maciej, Kim, Byoung Joon, Kim, Ho-Jin, Kim, Kwang-Kuk, Shin, Ha Young, Kim, Sung Min, Kim, Woojun, Oh, Jeeyoung, Bakhtiyarova, Klara Z., Belova, Anna N., Davydovskaya, Maria V., Dudin, Viacheslav A., Erina, Olesya V., Evdoshenko, Evgeny P., Greshnova, Irina V., Khabirov, Farit A., Kotov, Sergey V., Makarov, Nikolay S., Maslova, Natalia, Mishin, Gennadiy N., Pokhabov, Dmitry V., Smagina, Inna V., Spirin, Nikolay N., Trushnikova, Tatiana N., Volkova, Larisa I., Zaslavskiy, Leonid G., Zhukova, Natalia G., Ceranic, Mirjana, Cvijanovic, Vera, Drulovic, Jelena, Gavric Kezic, Mira, Jovanovic, Dragoslava, Milicevic, Svetlana K., Raicevic, Ranko, Suknjaja, Vesna, Boskovic Matic, Tatjana, Vojinovic, Slobodan, Ruiz, Luis Brieva, Castillo Trivino, Tamara, Costa-Frossard Franca, Lucienne, Eichau Madueno, Sara, Forero Diaz, Lucia, Martinez, Jose Enrique, Martinez Yelamos, Sergio, Meca Lallana, Virginia, Oreja Guevara, Celia, Ramio i Torrenta, Lluis, Arroyo Gonzalez, Rafael, Guo, Yuh-Cherng, Ro, Long-Sun, Tsai, Nai-Wen, Wang, Kai-Chen, Yang, Fu-Chi, Cherkez, Alla, Deineka, Natalia, Delva, Mykhaylo, Goloborodko, Alla, Hovbakh, Iryna, Khavunka, Marta, Kmyta, Oleksii, Kozyolkin, Olexandr, Lekomtseva, Yevgeniya, Litovchenko, Tetyana, Moskovko, Sergii, Pashkovskyy, Valeriy, Riabichenko, Tetiana, Tovazhnyanska, Olena, Voloshyna, Nataliya, Hrebeniuk, Hanna, Sokolova, Larysa, Arun, Tarunya, Constantinescu, Cris, Harrower, Timothy, Mattoscio, Miriam, Paling, David, Pearson, Owen, Robertson, Neil, Webb, Stewart, Cottrell, David, Nicholas, Richard, Duddy, Martin, Anadani, Nidhiben, Belkin, Martin, Bernitsas, Evanthia, Borazanci, Aimee, Clark, David, Costell, Brian, Delgado, Silvia, Fox, Edward, Gudesblatt, Mark, Gupta, Vipan, Harel, Asaff, Harrison, Daniel, Herrman, Craig, Honeycutt, William David, Hua, Le, Hunter, Samuel, Katsamakis, George, Kilgo, William, Koffman, Boyd, Lindsey, William, Lynch, Sharon G., Mateen, Farrah J., McAllister, Peter, Farahmand, Arya, Morales, Idanis Berrios, Rahmlow, Megan, Naismith, Robert, Napoli, Salvatore, Newman, Stephen, Pardo, Gabriel, Patel, Nirav, Scott, James, Purino, Lorraine, Vasquez, Alberto B., Weisman, David, Wray, Sibyl, Wynn, Daniel, Dihenia, Bhupesh, Obeidat, Ahmed, Ayala, Ricardo, Erwin, April, Betz, Michelle, DeAngelis, Teresa, Osborne Dusan Stefoski, Benjamin, Giang, Daniel, Hendin, Barry, Nagaraj, Arun, Saltis, Lawrence, Singer, Barry, Balabanov, Roumen, Bromley, Steven Michael, Puente, John, Tran, Duc, Kojan, Suleiman, Graves, Jennifer, Fishman, Simon, Maher, Leo, Londono, Diana, Sadiq, Mohamed, Alekseenko, Yuri, Fedulau, Aliaksandr, Kulesh, Sergey, Mikhailova, Elena, Navumava, Halina, Aragon deVecino, Maria Cecilia, Callegaro, Dagoberto, Daccach Marques, Vanessa, Finkelsztejn, Alessandro, Guerreiro, Alexandre, Kleinpaul, Rodrigo, Koiti Sato, Henry, Luiz Longo, Alexandre, Papais Alvarenga, Regina Maria, Pereira Damasceno, Benito, Pereira Gomes Neto, Antonio, Diniz Carneiro, Denise S., Tauil, Carlos Bernardo, Maciel Dias, Ronaldo, Olival, Guilherme, Zago Melo Dias, Paula, de Jesus Carvalho, Margarete, Sato, Douglas Kazutoshi, Forcelini, Cassiano Mateus, Pelov, Plamen, Haralanov, Lyubomir, Ikonomov, Rosen, Ivanov, Ivan, Kastrev, Sasho, Kirilov, Krasimir, Lilovski, Hristo, Maslarov, Dimitar, Staikov, Ivan, Zhelyazkov, Petko, Freedman, Mark, MacLean, Gregg, Marriott, James, McKelvey, John Roger, Girard, Jean-Marc, Vorobeychik, Galina, Morrow, Sarah, Clavelou, Pierre, de Seze, Jerome, Louapre, Celine, Maurousset, Aude, Ruet, Aurelie, Thouvenot, Eric, Morel, Nathalie, Montcuquet, Alexis, Rouhart, Francois, Angstwurm, Klemens, Bayas, Antonios, Bittner, Stefan, Heesen, Christoph, Kowarik, Markus, Marckmann-Boenke, Silke, Muller, Thomas, Zimmermann, Julian, Nelles, Gereon, Paul, Friedemann, Then Bergh, Florian, Wildemann, Brigitte, Zettl, Uwe Klaus, Ziemssen, Tjalf, Doerr, Jan-Marcus, Chroni, Elisabeth, Dardiotis, Efthymios, Doskas, Triantafyllos, Gatzonis, Stylianos, Grigoriadis, Nikolaos, Karageorgiou, Klimentini, Kouremenos, Evangelos, Mitsias, Panayiotis, Spengos, Konstantinos, Kimiskidis, Vasilios, Evangelopoulos, Maria E., Fakas, Nikolaos, Karanasios, Panagiotis, Kyritsis, Athanasios, Maltezou, Maria, Sotirli, Stefania, Tsolaki, Magda, Rohtagi, Anshu, Mukherjee, Joy, Nellikunja, Shankara, Srinivasa, Rangashetty, Sharma, Arvind, Chowdhury, Debashish, Kalita, Jayantee, Brescia Morra, Vincenzo, Centonze, Diego, Gasperini, Claudio, Grimaldi, Luigi, Maniscalco, Giorgia Teresa, Patti, Francesco, Salemi, Giuseppe, Trojano, Maria, Amato, Maria Pia, Malucchi, Simona, Brambilla, Laura, Pozzilli, Carlo, Al Roughani, Raed, Karelis, Guntis, Kalnina, Jolanta, Millers, Andrejs, Mickeviciene, Dalia, Giedraitiene, Natasa, Kazlauskas, Andrius, Malciene, Lina, Joseph, Joyce Pauline, Chung, Law Wan, Looi, Irene, Remli, Rabani, Binti Sapuan, Sapiah, Abdullah, Suhailah, Carbajal Ramirez, Angelica, Espino Ojeda, Alba, Silvestre Bejar Medina, Jesus, Quinones Aguilar, Sandra, Rivas Alonso, Veronica, de la Rosa, Rogelio Francisco, San Juan Orta, Daniel, Misic, Octavian, Odainic, Olesea, Torkildsen, Oivind, Schuler, Stephan, Broch, Line, Canete, Ma. Teresa, Hiyadan, John Harold, Hormillosa, Mary Pauline, Rosales, Raymond L., Adamczyk Sowa, Monika, Bartosik-Psujek, Halina, Berkowicz, Tomasz, Czarnecki, Maciej, Kłodowska, Gabriela, Klosek, Agata, Koscielniak, Jozef, Lisewski, Pawel, Mielcarek, Bartlomiej, Piasecka-Stryczynska, Karolina, Potemkowski, Andrzej, Stasiołek, Mariusz, Krzystanek, Ewa, Lasek-Bal, Anetta, Sikorska, Swietlana, Szczudlik, Andrzej, Gospodarczyk-Szot, Krystyna, Wierzchowska-Cioch, Ewa, K. Jastrzebska, Iwona, Capela, Carlos, Cerqueira, Joao, Correia, Ana Sofia, Correia, Filipe, Ferreira, Joaquim J., Gouveia, Raquel, Mendes, Irene, Nunes, Carla Cecilia, Timoteo, Angela, Veira, Carlos, Martins da Silva, Ana, Domingues, Joana, Chinea, Angel R, Tiu, Cristina, Balasa, Rodica, Chiru, Mirela, Dulamea, Adriana Octaviana, Silviu Manescu, Emilian, Mitrea, Dan, Mitu, Cristina, Nicolae, Silvia Maria, Filip, Carmen Corina Roman, Sabau, Monica, Vanghelie, Doinita, Varga, Ioana, Nunkoo, Vharoon, Agafina, Alina S., Gennadevna, Arefeva Elena, Alexeeva, Tatiana M., Bogdanov, Enver, Dorogov, Nikolay, Doronina, Olga, Goncharova, Zoya, Khasanova, Dina, Korobko, Denis, Pankratov, Evgeny V., Parshina, Elena, Poverennova, Irina, Prokopenko, Semyion V., Sazonov, Denis V., Shkilnyuk, Galina, Sivertseva, Stella, Stolyarov, Igor, Totolyan, Natalia A., Tsukurova, Larisa A., Vorobyeva, Olga V., Voznyuk, Igor A., Zakharova, Maria, Ardashev, Igor V., Boyko, Alexey, Alshehri, Ebtesam, Alkhawajah, Nuha M, Alfugham, Nora, Quek, Amy, Kevin, Tan, Dupejova, Beata, Feketova, Sona, Hancinova, Viera, Jurcaga, Frantisek, Turcani, Peter, Krastev, Georgi, Cimprichova, Andrea, Perichtova, Magdalena, Hojs-Fabjan, Tanja, Horvat Ledinek, Alenka, Savsek, Lina, Bateman, Kathleen, Frost, Andrew Charles, Henning, Franclo, Retief, Chris Francois, Aguado Valcarcel, Marta, Morales, Eduardo Aguera, Alonso Torres, Ana Maria, Borrega Canelo, Laura, Casanova Estruch, Bonaventura, Gascon Gimenez, Francisco, Ayuso, Guillermo I, Martinez Gines, Maria Luisa, Eustasio Meca Lallana, Jose, Rodriguez Antiguedad, Alfredo, Blasco Quilez, Rosario, Brieva Ruiz, Luis, Piehl, Fredrik, Lycke, Jan, Katsarogiannis, Evangelos, Nilsson, Christer, Hoepner, Robert, Zecca, Chiara, Findling, Oliver, Asawavichienjinda, Thanin, Kasemsap, Narongrit, Prayoonwiwat, Naraporn, Mhiri, Chokri, Ağan Yıldırım, Kadriye, Boz, Cavit, Efendi, Husnu, Soysal, Aysun, Terzi, Murat, Uygunoglu, Ugur, Gümüş, Haluk, Mungan, Semra, Ozakbas, Serkan, Serhan Sevim, Mustafa, Tamam, Yusuf, Kale, Nilufer, Karabudak, Rana, Bachinskaya, Natalia, Buchakchyiska, Nataliia, Chmyr, Galyna, Dzyak, Ludmyla, Ivashchenko, Svitlana, Kalbus, Oleksandr, Kareta, Serhiy, Korolova, Oksana, Kostiuchenko, Andrii, Kruchkevych, Zhanna, Larysa, Kadina, Mishchenko, Tamara, Moroz, Olena, Neryanova, Yuliya, Pasiura, Ihor, Pohrebnyak, Oleksandr, Pryshchepa, Volodymyr, Sanotskyy, Yanosh, Shkrobot, Svitlana, Shulga, Olga, Smolanka, Volodymyr, Tomakh, Nataliya, Zhuravlyova, Natalia, Allen, Alison B., Armstrong, Robert, Antezana, Ariel, Baker, Matthew, Bass, Ann, Benenati, Diana, Benson, Dalton, Beretich, Biljana, Burke, Deborah, Calkwood, Jonathan, Carpenter, Adam, Drake, Ryan, Dujmovic Basuroski, Irena, Gupta, Ajay, Hentati, Afif, Kaplan, Jeffrey, Katsafanas, Constance, Keegan, Andrew, Khatri, Bhupendra, Luzzio, Christopher, Malik, Maheen, Bennette, Myers, Miravalle, Augusto, Montoya, Liliana, Nash, Marshall, Poole Pharr, Emily, Sater, Richard A., Scagnelli, John, Schulman, Alan, Shafer, Stuart, Stein, Lee, Vandersluis, Joel, Williams, Armistead, Winkley, James, Berkovich, Regina, Cerghet, Mirela, Horton, Lindsay, Jacobs, Daniel H., Laurin, Nida, Liow, Kore, Robertson, Derrick, Mattson, David, Cabrera, Alicia V., Leist, Thomas, Negroski, Donald, Royter, Vladimir, LaGanke, Christopher, Winner, Paul, Sweeney, Michael, Weinberg, Lawrence A., Smith, Andrew, Rivas-Rodriguez, Erica, Wagner, Kimberly, Montalban, Xavier, Vermersch, Patrick, Arnold, Douglas L, Bar-Or, Amit, Cree, Bruce A C, Cross, Anne H, Kubala Havrdova, Eva, Kappos, Ludwig, Stuve, Olaf, Wiendl, Heinz, Wolinsky, Jerry S, Dahlke, Frank, Le Bolay, Claire, Shen Loo, Li, Gopalakrishnan, Sathej, Hyvert, Yann, Javor, Andrija, Guehring, Hans, Tenenbaum, Nadia, and Tomic, Davorka

Published
2024
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18. Safety, tolerability, and activity of mesenchymal stem cells versus placebo in multiple sclerosis (MESEMS): a phase 2, randomised, double-blind crossover trial

Author

Aghdami, Naser, Agüera-Morales, Eduardo, Ali, Rehiana, Allan, David, Arab, Leila, Battaglia, Mario, Berry, Isabelle, Blinkenberg, Morten, Bonetti, Bruno, Brundin, Lou, Capelli, Chiara, Castellan, Lucio, Cellerino, Maria, Cencioni, Maria Teresa, Clanet, Michel, Comi, Giancarlo, Courtman, David, Dazzi, Francesco, Fischer-Nielsen, Anne, Fernandez, Oscar, Fernandez, Victoria, Freedman, Mark S., Furlan, Roberto, Gimona, Mario, Gualandi, Francesca, Guan, Qingdong, Iacobaeus, Ellen, Inglese, Matilde, Introna, Martino, Izquierdo, Guillermo, Karimi, Shahedeh, Laroni, Alice, Le Blanc, Katarina, Loaiza, Sandra, Mallik, Shahrukh, Marley, Stephen, Marrie, Ruth Ann, Marriot, James, Martino, Gianvito, Nabavi, Seyed Massood, Miller, David, Muraro, Paolo A., Nicholas, Richard, Oliveri, Roberto S, Orengo, Giovanni, Palanicawande, Renuka, Pardini, Matteo, Radue, Ernst W, Ramo Tello, Cristina, Rush, Carolina, Schiavetti, Irene, Sellner, Johann, Sensebe, Luc, Soelberg Sorensen, Per, Sormani, Maria Pia, Strunk, Dirk, Szwajcer, David, Thalamas, Claire, Uccelli, Antonio, Wuerfel, Jens Thomas, Battaglia, Mario Alberto, Marriott, James, Muraro, Paolo, Radue, Ernst, Sorensen, Per Soelberg, and Freedman, Mark S

Published
2021
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20. Contributors

Author

Abzug, Mark J., primary, Acharya, Priyamvada, additional, Acosta, Anna M., additional, Ahmed, S. Sohail, additional, Amanna, Ian J., additional, Anderson, Annaliesa S., additional, Asturias, Edwin J., additional, Bachmann, Martin F., additional, Bahl, Sunil, additional, Bailey, Justin R., additional, Baker, Carol J., additional, Balfour, Henry H., additional, Baric, Ralph S., additional, Barnett, Elizabeth D., additional, Barrett, Alan D.T., additional, Belser, Jessica A., additional, Berzofsky, Jay A., additional, Bethony, Jeffrey M., additional, Brewer-Jensen, Paul D., additional, Bubak, Andrew N., additional, Burns, Cara C., additional, Caplan, Arthur L., additional, Cavaleri, Marco, additional, Chandran, Aruna, additional, Cherian, Thomas, additional, Clemens, John D., additional, Cochino, Emil, additional, Cohet, Catherine, additional, Cohn, Amanda, additional, Cortese, Margaret M., additional, Crowcroft, Natasha S., additional, Curtis, Nigel, additional, Damron, F. Heath, additional, Danchin, Margie, additional, Debbink, Kari, additional, Desai, Sachin N., additional, Davis, Emily H., additional, Decker, Michael D., additional, Denison, Mark R., additional, DeStefano, Frank, additional, Douglas, R. Gordon, additional, Dreher-Lesnick, Sheila M., additional, Eberhardt, Christiane S., additional, Edmunds, W. John, additional, Edwards, Caitlin E., additional, Edwards, Kathryn M., additional, Eggers, Rudolf, additional, Ellis, Ronald, additional, Erdman, Dean D., additional, Ertl, Hildegund C.J., additional, Estivariz, Concepcion F., additional, Fine, Paul E.M., additional, Finn, Theresa M., additional, Fisher, Allison M., additional, Fitzwater, Sean Patrick, additional, Freedman, Mark S., additional, Friede, Martin, additional, Friedlander, Arthur M., additional, Frumento, Nicole, additional, Fry, Alicia M., additional, Garçon, Nathalie, additional, Geris, Jennifer M., additional, Gershon, Anne A., additional, Gervier, Regis, additional, Gessner, Bradford D., additional, Gilbert, Peter B., additional, Gomez, Phillip Louis, additional, Ginsberg, Ann M., additional, Grabenstein, John D., additional, Graham, Rachel L., additional, Graham, Barney S., additional, Granoff, Dan M., additional, Gray, Gregory C., additional, Greenberg, David P., additional, Grohskopf, Lisa A., additional, Gruber, Marion F., additional, Guerena, Fernando B., additional, Havelange, Nicolas, additional, Halstead, Scott B., additional, Hanekom, Willem A., additional, Harrison, Lee H., additional, Hawn, Thomas R., additional, Haynes, Barton F., additional, Healy, C. Mary, additional, Hills, Susan L., additional, Hirabayashi, Kuniko, additional, Holmgren, Jan, additional, Hombach, Joachim M., additional, Hotez, Peter Jay, additional, Howe, Barbara J., additional, Hunegnaw, Ruth, additional, Izopet, Jacques, additional, Jamieson, Denise J., additional, Jansen, Kathrin, additional, Jarrahian, Courtney, additional, Johansen, Kari, additional, Kahn, Geoffrey D., additional, Karron, Ruth A., additional, Katz, Jacqueline M., additional, Kennedy, Richard B., additional, Broojerdi, Alireza Khadem, additional, Khetsuriani, Nino, additional, Khudyakov, Yury, additional, Klugman, Keith P., additional, Kocher, Jacob F., additional, Kollaritsch, Herwig, additional, Kotloff, Karen L., additional, Kozarsky, Phyllis E., additional, Kreimer, Aimée R., additional, Kroger, Andrew T., additional, Kwong, Peter D., additional, Lal, Manjari, additional, Levin, Myron J., additional, Levine, Myron M., additional, Lindesmith, Lisa C., additional, Lindstrand, Ann, additional, Ljungman, Per, additional, Lowy, Douglas R., additional, Lundgren, Anna, additional, Lydon, Patrick, additional, Macklin, Grace R., additional, Maeng, Hoyoung M., additional, Mahalingam, Ravi, additional, Malley, Richard, additional, Mallory, Michael L., additional, Marfin, Anthony A., additional, Markowitz, Lauri E., additional, Marshall, CDR Valerie, additional, McCollum, Andrea, additional, Meyer, Sarah, additional, McNamara, Lucy A., additional, Menning, Lisa, additional, Messacar, Kevin, additional, Miller, Mark A., additional, Milutinovic, Pavle, additional, Modlin, John F., additional, Monath, Thomas P., additional, Morabito, Kaitlyn M., additional, Moss, William J., additional, Mulholland, Kim, additional, Mura, Manuela, additional, Musher, Daniel M., additional, Nagel, Maria A., additional, Nair, G. Balakrish, additional, Nelson, Noele P., additional, Netea, Mihai G., additional, Neuzil, Kathleen Maletic, additional, Niemeyer, Christy S., additional, Nohynek, Hanna, additional, Norheim, Gunnstein, additional, Nussbaum, Lauren, additional, O’Brien, Katherine L., additional, O’Leary, Sean, additional, Ockenhouse, Christian, additional, Offit, Paul A., additional, Okwo-Bele, Jean-Marie, additional, Olkhanud, Purevdorj B., additional, Omer, Saad B., additional, Orenstein, Walter A., additional, Oyston, Petra C.F., additional, Parashar, Umesh D., additional, Patel, Manish M., additional, Payne, Daniel C., additional, Pebody, Richard, additional, Pecetta, Simone, additional, Perlman, Stanley, additional, Pierson, Benjamin, additional, Pierson, Theodore C., additional, Pittet, Laure F., additional, Pittman, Phillip R., additional, Plotkin, Stanley A., additional, Plotkin, Susan L., additional, Poland, Gregory A., additional, Pollard, Sir Andrew John, additional, Poovorawan, Yong, additional, Proctor, Richard A., additional, Qadri, Firdausi, additional, Rao, Agam, additional, Rappuoli, Rino, additional, Reef, Susan E., additional, Rogalewicz, Joseph A., additional, Robinson, James Michael, additional, Roesel, Sigrun, additional, Rubin, Steven A., additional, Rupprecht, Charles E., additional, Rutter, Paul, additional, Samant, Vijay B., additional, Sambhara, Suryaprakash, additional, Samies, Nicole L., additional, Santosham, Mathuram, additional, Saunders, Kevin O., additional, Schiller, John T., additional, Schleiss, Mark R., additional, Schuerman, Lode, additional, Schwab, Jennifer, additional, Schwartz, Jason L., additional, Scobie, Heather M., additional, Scott, J. Anthony, additional, Shapiro, Eugene D., additional, Shenoy, Erica S., additional, Shimabukuro, Tom T., additional, Shouval, Daniel, additional, Siegrist, Claire-Anne, additional, Sitrin, Robert D., additional, Skinner, Nicole E., additional, Slifka, Mark K., additional, Sodha, Samir V., additional, Soeters, Heidi M., additional, Solomon, Tom, additional, Speiser, Daniel E., additional, Staples, J. Erin, additional, Steffen, Robert, additional, Stephens, David S., additional, Strebel, Peter M., additional, Subbarao, Kanta, additional, Sullivan, Nancy J., additional, Takashima, Yoshihiro, additional, Tate, Jacqueline E., additional, Tayman, Alice, additional, Telford, Sam R., additional, Thombley, Melisa, additional, Thomsen, Isaac, additional, Tohme, Rania A., additional, Trabold, Malin, additional, El-Turabi, Aadil, additional, Vaughn, David W., additional, Verardi, Raffaello, additional, Vicari, Andrea S., additional, Vidor, Emmanuel J., additional, Villafana, Tonya, additional, Vogt, Matthew R., additional, Walker, Mark J., additional, Walsh, Nick M., additional, Wanlapakorn, Nasamon, additional, Ward, John W., additional, Wassilak, Steven G.F., additional, Watts, Lisa A., additional, Weber, David J., additional, Weiner, David B., additional, Weng, Mark K., additional, Wexler, Deborah L., additional, Wharton, Melinda, additional, Whitley, Richard J., additional, Whitney, Cynthia G., additional, Wiehe, Kevin, additional, Williamson, E. Diane, additional, Wormser, Gary P., additional, Xia, Ningshao, additional, Yildirim, Inci, additional, Zehrung, Darin, additional, and Zweigart, Mark R., additional

Published
2023
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23. Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Reingold, Stephen, Duquette, Pierre, Derfuss, Tobias, Fazekas, Franz, Sormani, Maria Pia, Lisak, Robert P., Graves, Jennifer, Krieger, Stephen, Zabad, Rana K., Newsome, Scott, Barton, Joshua, MacDonell, Richard, Marriott, Mark, De Klippel, Nina, Laureys, Guy, Willekens, Barbara, Devonshire, Virginia, Freedman, Mark, Girard, J Marc, Giacomini, Paul, McKelvey, Roger, Selchen, Daniel, Vorobeychik, Galina, Witkowski, Ludivine, Ampapa, Radek, Preiningerova, Jana Lizrova, Meluzinova, Eva, Talab, Radomir, Vachova, Marta, Aktas, Orhan, Buttmann, Mathias, Birte, Elias-Hamp, Kuempfel, Tania, Friedemann, Paul, Rau, Daniela, Reifschneider, Gerd, Sokolowski, Piotr, Tumani, Hayrettin, Satori, Maria, Pozzilli, Carlo, Klosek, Agata, Koscielniak, Jozef, Waldemar, Fryze, Zajda, Malgorzata, Gonzalez, Rafael Arroyo, Ayuso, Guillermo Izquierdo, Sanchez, Victoria Fernandez, Guevara, Celia Oreja, Rodriguez, Jose Enrique Martinez, Montalban, Xavier, Ramio-Torrenta, Lluis, Brundin, Lou, Lycke, Jan, Terzi, Murat, Guadagno, Joe, Mahad, Don, Pace, Adrian, Schmierer, Klaus, Toosy, Ahmed, Webb, Stewart, Agius, Mark, Amezcua, Lilyana, Apperson, Michelle, Bagert, Bridget, Bandari, Daniel, Bernitsas, Evanthia, Calkwood, Jonathan, Carter, Jonathan, Cohen, Bruce, Conway, Devon, Cooper, Joanna, Corboy, John, Coyle, Patricia, Cree, Bruce, Freedman, Mitchel, Ford, Corey, Fox, Edward, Goldman, Myla, Greenberg, Benjamin, Kita, Mariko, Leist, Thomas, Lynch, Sharon, Miller, Aaron, Moses, Harold, Naismith, Robert, Picone, Mary Ann, Perminder, Bhatia, Rae-Grant, Alexander, Rammohan, Kottil, Reder, Anthony, Riley, Claire, Robertson, Derrick, Rowe, Vernon, Saidha, Shiv, Samkoff, Lawrence, Severson, Christopher, Smoot, Kyle, Stoll, Sharon, Trudell, Randall, Weinstock-Guttman, Bianca, Yathiraj, Sanjay, Cree, Bruce A C, Cutter, Gary, Wolinsky, Jerry S, Freedman, Mark S, Comi, Giancarlo, Giovannoni, Gavin, Hartung, Hans-Peter, Arnold, Douglas, Kuhle, Jens, Block, Valerie, Munschauer, Frederick E, Sedel, Frédéric, and Lublin, Fred D

Published
2020
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25. Long-term follow-up of patients with a first clinical demyelinating event (clinically isolated syndrome) who received cladribine tablets in CLASSIC-MS: Findings for the ORACLE-MS cohort.

Author

Giovannoni, Gavin, Boyko, Alexey, Correale, Jorge, Edan, Gilles, Freedman, Mark S, Montalban, Xavier, Rammohan, Kottil, Stefoski, Dusan, Yamout, Bassem, Leist, Thomas, Aydemir, Aida, Borsi, Laszlo, and Verdun di Cantogno, Elisabetta

Abstract

Background: CLASSIC-MS explored long-term outcomes of patients treated with cladribine tablets. Objective: Assess long-term efficacy in patients previously enrolled in ORACLE-MS, a Phase III parent trial. Methods: ORACLE-MS included patients with a first clinical demyelinating event (FCDE or clinically isolated syndrome) who received ⩾1 course of cladribine tablets or placebo. With a median follow-up time of 9.5 years, CLASSIC-MS assessed conversion rates to clinically definite multiple sclerosis (CDMS), time-to-conversion, relapse rates, long-term mobility/disability status and subsequent disease-modifying therapy (DMT) use. Results: Of 227 patients from the ORACLE-MS cohort of 616, 68.7% were exposed to cladribine tablets and 31.3% were never exposed. Of the exposed patients at risk, 51.5% converted to CDMS with a median conversion time of 8.4 (95% confidence interval (CI): 5.4–not estimable) years, versus 80.6%, median time 0.8 (95% CI: 0.3–2.4) years, for never exposed. Exposed patients were less likely to be using a wheelchair or ambulatory device or receive subsequent DMTs, and 53.2% were relapse-free versus 28.2% never exposed. Conclusions: Proportionally, more FCDE patients exposed to cladribine tablets experienced delayed conversion to CDMS and fewer relapses and were less likely to use a wheelchair or ambulatory device than never-exposed patients, at 9.5 years (median). [ABSTRACT FROM AUTHOR]

Published
2025
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29. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study

Author

Miller, David H, Lublin, Fred D, Sormani, Maria Pia, Kappos, Ludwig, Yaldizli, Özgür, Freedman, Mark S, Cree, Bruce AC, Weiner, Howard L, Lubetzki, Catherine, Hartung, Hans‐Peter, Montalban, Xavier, Uitdehaag, Bernard MJ, MacManus, David G, Yousry, Tarek A, Wheeler‐Kingshott, Claudia AM Gandini, Li, Bingbing, Putzki, Norman, Merschhemke, Martin, Häring, Dieter A, and Wolinsky, Jerry S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Biomedical Imaging, Aging, Multiple Sclerosis, Neurodegenerative, Neurosciences, Brain Disorders, Neurological, Clinical and health psychology
Abstract

ObjectiveTo investigate the relationship between brain volume and disability worsening over ≥3 years in the natural history of primary progressive multiple sclerosis using data from the placebo group of the INFORMS trial (n = 487; clinicaltrials.gov NCT00731692).MethodsMagnetic resonance imaging scans were collected annually. Brain volume loss was determined using SIENA. Patients were stratified by baseline normalized brain volume after adjusting for demographic and disease-burden covariates.ResultsBaseline normalized brain volume was predictive of disability worsening: Risk of 3-month confirmed disability progression was reduced by 36% for high versus low baseline normalized brain volume (Cox's model hazard ratio 0.64, P = 0.0339; log-rank test: P = 0.0297). Moreover, on-study brain volume loss was significantly associated with disability worsening (P = 0.012) and was evident in patients with or without new lesions or relapses. Brain volume loss depended significantly on baseline T2 lesion volume (P

Published
2018

31. Health Canada drug approval process: a barrier to personalized care in multiple sclerosis

Author

Oh, Jiwon, primary, Bhan, Virender, additional, Traboulsee, Anthony, additional, Morrow, Sarah A., additional, Lee, Liesly, additional, Levin, Michael, additional, Casserly, Courtney, additional, Freedman, Mark S., additional, Giacomini, Paul S., additional, Émond, François, additional, Smyth, Penelope, additional, Clift, Fraser, additional, and Selchen, Daniel, additional

Published
2024
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36. The efficacy of cladribine tablets in CIS patients retrospectively assigned the diagnosis of MS using modern criteria: Results from the ORACLE-MS study

Author

Freedman, Mark S, Leist, Thomas P, Comi, Giancarlo, Cree, Bruce AC, Coyle, Patricia K, Hartung, Hans-Peter, Vermersch, Patrick, Damian, Doris, and Dangond, Fernando

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Neurodegenerative, Brain Disorders, Clinical Trials and Supportive Activities, Autoimmune Disease, Multiple Sclerosis, Neurosciences, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Cladribine tablets, McDonald 2010 criteria, clinically isolated syndrome, conversion to clinically definite multiple sclerosis, early multiple sclerosis, efficacy, Epidemiology, Health services and systems
Abstract

BackgroundMultiple sclerosis (MS) diagnostic criteria have changed since the ORACLE-MS study was conducted; 223 of 616 patients (36.2%) would have met the diagnosis of MS vs clinically isolated syndrome (CIS) using the newer criteria.ObjectiveThe objective of this paper is to assess the effect of cladribine tablets in patients with a first clinical demyelinating attack fulfilling newer criteria (McDonald 2010) for MS vs CIS.MethodsA post hoc analysis for subgroups of patients retrospectively classified as fulfilling or not fulfilling newer criteria at the first clinical demyelinating attack was conducted.ResultsCladribine tablets 3.5 mg/kg (n = 68) reduced the risk of next attack or three-month confirmed Expanded Disability Status Scale (EDSS) worsening by 74% vs placebo (n = 72); p = 0.0009 in patients meeting newer criteria for MS at baseline. Cladribine tablets 5.25 mg/kg (n = 83) reduced the risk of next attack or three-month confirmed EDSS worsening by 37%, but nominal significance was not reached (p = 0.14). In patients who were still CIS after applying newer criteria, cladribine tablets 3.5 mg/kg (n = 138) reduced the risk of conversion to clinically definite multiple sclerosis (CDMS) by 63% vs placebo (n = 134); p = 0.0003. Cladribine tablets 5.25 mg/kg (n = 121) reduced the risk of conversion by 75% vs placebo (n = 134); p

Published
2017

41. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension

Author

Bartholomé, Emmanuel, D'Hooghe, Marie, Pandolfo, Massimo, Van Wijmeersch, Bart, Bhan, Virender, Blevins, Gregg, Brunet, Donald, Devonshire, Virginia, Duquette, Pierre, Freedman, Mark, Grand'Maison, François, Jacques, François, Lapierre, Yves, Lee, Liesly, Morrow, Sarah, Yeung, Michael, Dufek, Michal, Havrdová, Eva Kubala, Kanovsky, Petr, Stetkarova, Ivana, Talabova, Marika, Frederiksen, Jette, Kant, Matthias, Petersen, Thor, Ravnborg, Mads, Sellebjerg, Finn, Airas, Laura, Elovaara, Irina, Eralinna, Juha-Pekka, Sarasoja, Taneli, Al Khedr, Abdullatif, Brassat, David, Brochet, Bruno, Camu, William, Debouverie, Marc, Laplaud, David, Lebrun Frenay, Christine, Pelletier, Jean, Vermersch, Patrick, Vukusi, Sandra, Baum, Karl, Berthele, Achim, Faiss, Juergen, Flachenecker, Peter, Hohlfeld, Reinhard, Krumbholz, Markus, Lassek, Christoph, Maeurer, Mathias, Meuth, Sven, Ziemssen, Tjalf, Hardiman, Orla, McGuigan, Christopher, Achiron, Anat, Karussis, Dimitrios, Bergamaschi, Roberto, Morra, Vincenzo Brescia, Comi, Giancarlo, Cottone, Salvatore, Grimaldi, Luigi, Mancardi, Giovanni Luigi, Massacesi, Luca, Nocentini, Ugo, Salvetti, Marco, Scarpini, Elio, Sola, Patrizia, Tedeschi, Gioacchino, Trojano, Maria, Zaffaroni, Mauro, Frequin, Stephan, Hupperts, Raymond, Killestein, Joep, Schrijver, Hans, Van Dijl, Ronald, van Munster, Erik, Czarnecki, Maciej, Drozdowski, Wieslaw, Fryze, Waldemar, Hertmanowska, Hanka, Ilkowski, Jan, Kaminska, Anna, Klodowska-Duda, Gabriela, Maciejowski, Maciej, Motta, Ewa, Podemski, Ryszard, Potemkowski, Andrzej, Rog, Teresa, Selmaj, Krzysztof, Stelmasiak, Zbigniew, Stepien, Adam, Tutaj, Andrzej, Zaborski, Jacek, Boyko, Alexey, Chefranova, Zanna, Evdoshenko, Evgeny, Khabirov, Farit, Sivertseva, Stella, Yakupov, Eduard, Alvarez Cermeño, Jose Carlos, Escartin, Antonio, Fernandez, Oscar Fernandez, Garcia-Merino, Antonio, Hernandez Perez, Miguel Angel, Ayuso, Guillermo Izquierdo, Lallana, José Meca, Gairin, Xavier Montalban, Oreja-Guevara, Celia, Saiz Hinarejos, Albert, Gunnarsson, Martin, Lycke, Jan, Martin, Claes, Piehl, Fredrik, Roshanisefat, Homayoun, Sundstrom, Peter, Duddy, Martin, Gran, Bruno, Harrower, Timothy, Hobart, Jeremy, Kapoor, Raju, Lee, Martin, Mattison, Paul, Nicholas, Richard, Pearson, Owen, Rashid, Waqar, Rog, David, Sharrack, Basil, Silber, Eli, Turner, Ben, Williams, Anna, Woolmore, John, Young, Carolyn, Bandari, Daniel, Berger, Joseph, Camac, Ann, Cohan, Stanley, Conway, Jill, Edwards, Keith, Fabian, Michelle, Florin, Jack, Freedman, Steven, Garwacki, Dennis, Goldman, Myla, Harrison, Daniel, Herrman, Craig, Huang, Deren, Javed, Adil, Jeffery, Douglas, Kamin, Stephen, Katsamakis, George, Khatri, Bhupendra, Langer-Gould, Annette, Lynch, Sharon, Mattson, David, Miller, Tamara, Miravalle, Augusto, Moses, Harold, Muley, Suraj, Napier, James, Nielsen, Allen, Pachner, Andrew, Pardo, Gabriel, Picone, MaryAnn, Robertson, Derrick, Royal, Walter, Sheppard, Christopher, Thrower, Ben, Twyman, Cary, Waubant, Emmanuelle, Wendt, Jeanette, Yadav, Vijayshree, Zabad, Rana, Zarelli, Greg, Ho, Pei-Ran, Campbell, Nolan, Chang, Ih, Deykin, Aaron, Forrestal, Fiona, Lucas, Nisha, Yu, Bei, Arnold, Douglas L, Freedman, Mark S, Goldman, Myla D, Hartung, Hans-Peter, Miller, Aaron, Cadavid, Diego, Mikol, Dan, and Steiner, Deborah

Published
2018
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42. Is there a prodrome to NMOSD? An investigation of neurologic symptoms preceding the first NMOSD attack.

Author

Lee, Sydney, Marrie, Ruth Ann, Fadda, Giulia, Freedman, Mark S, Lee, Liesly, Muccilli, Alexandra, Vyas, Manav V, Konig, Andrea, and Rotstein, Dalia L.

Subjects
MAGNETIC resonance imaging, DEMYELINATION, NEURALGIA, SPINAL cord, SPASMS, PRODROMAL symptoms, NEUROMYELITIS optica
Abstract

Background: It is unknown whether people with aquaporin-4 antibody positive (AQP4-IgG+) neuromyelitis optica spectrum disorder (NMOSD) experience a prodrome, although a few cases report AQP4 + serology up to 16 years before the first attack. Objectives: To evaluate whether individuals with AQP4-IgG + NMOSD have prodromal neurologic symptoms preceding the first attack. Methods: We reviewed medical records of participants meeting the 2015 diagnostic criteria for AQP4-IgG + NMOSD from four demyelinating disease centres in the Canadian NMOSD cohort study CANOPTICS. We searched for neurologic symptoms occurring at least 30 days before the first attack. Results: Of 116 participants with NMOSD, 17 (14.7%) had prodromal neurologic symptoms. The median age was 48 years (range 25–83) at first attack; 16 (94.1%) were female. Participants presented with numbness/tingling (n = 9), neuropathic pain (n = 5), visual disturbance (n = 4), tonic spasms (n = 2), Lhermitte sign (n = 2), severe headache (n = 2), incoordination (n = 2), weakness (n = 1), psychosis (n = 1) or seizure (n = 1). Of eight who underwent magnetic resonance imaging (MRI) brain, orbits and/or spinal cord, five had T2 lesions. Within 1.5–245 months (median 14) from the onset of prodromal neurologic symptoms, participants experienced their first NMOSD attack. Conclusions: One in seven people with NMOSD experienced neurologic symptoms before their first attack. Further investigation of a possible NMOSD prodrome is warranted. [ABSTRACT FROM AUTHOR]

Published
2024
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43. Investigation of health care use and a possible prodrome before the first attack in NMOSD and MOGAD.

Author

Rotstein, Dalia L, Freedman, Mark S, Konig, Andrea, Lee, Liesly, Luo, Jin, Maxwell, Colleen, Morrow, Sarah A, Tremlett, Helen, Vyas, Manav V, and Marrie, Ruth Ann

Subjects
*NEUROMYELITIS optica, *MYELIN oligodendrocyte glycoprotein, *MEDICAL care use, *AQUAPORINS, *NEURODEGENERATION, *PRODROMAL symptoms
Abstract

Background: Prodromal phases are well recognized in many inflammatory and neurodegenerative diseases, including multiple sclerosis. We evaluated the possibility of a prodrome in aquaporin-4 antibody positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD) and myelin oligodendrocyte glycoprotein antibody disease (MOGAD) using health administrative data. Methods: We investigated individuals with AQP4 + NMOSD and MOGAD, confirmed by medical chart review, in Ontario, Canada. Each NMOSD and MOGAD participant was matched 1:5 to general population controls by sex, birth year, immigrant status, and region. Total outpatient visits and hospitalizations were compared in the 5 years preceding the incident attack in multivariable negative binomial models. Results: We identified 96 people with AQP4 + NMOSD, matched to 479 controls, and 61 people with MOGAD, matched to 303 controls. In the 5 years preceding the incident attack, health care use was elevated for outpatient visits and hospitalizations for the NMOSD cohort (adjusted rate ratio (aRR): 1.47; 95% confidence interval (CI): 1.25–1.73; aRR: 1.67; 95% CI: 1.19–2.36, respectively) but not for MOGAD. Rate ratios steadily increased in NMOSD for outpatient visits in the 2 years preceding the incident attack. Conclusion: Our findings support a prodromal phase preceding clinical onset of AQP4 + NMOSD. Earlier recognition and management of NMOSD patients may be possible. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Effectiveness of autologous haematopoietic stem cell transplantation versus natalizumab in progressive multiple sclerosis.

Author

Kalincik, Tomas, Sharmin, Sifat, Roos, Izanne, Massey, Jennifer, Sutton, Ian, Withers, Barbara, Freedman, Mark S, Atkins, Harold, Krasulova, Eva, Havrdova, Eva Kubala, Trneny, Marek, Kozak, Tomas, Burman, Joachim, Macdonell, Richard, Torkildsen, Øivind, Bø, Lars, Lehmann, Anne Kristine, Sharrack, Basil, and Snowden, John

Subjects
HEMATOPOIETIC stem cell transplantation, MEDICAL sciences, MEDICAL research, HEMATOPOIETIC stem cells, RESPIRATORY infections, FEBRILE neutropenia
Published
2024
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47. Low Disease Activity Over 4 Years of Ocrelizumab Therapy in Treatment-naive Patients with High-activity, Early-stage Relapsing-remitting Multiple Sclerosis in the ENSEMBLE Study (P10-6.007)

Author

Vollmer, Timothy, primary, Bermel, Robert, additional, Brochet, Bruno, additional, Berger, Thomas, additional, Carroll, William, additional, Freedman, Mark, additional, Holmoy, Trygve, additional, Karabudak, Rana, additional, Killestein, Joep, additional, Nos, Carlos, additional, Patti, Francesco, additional, Vanopdenbosch, Ludo, additional, Kuenzel, Thomas, additional, Kadner, Karen, additional, Kulyk, Inessa, additional, and Hartung, Hans-Peter, additional

Published
2024
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