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6 results on '"Michael Nicolle"'

1. Development of myasthenia gravis in a patient with chronic myeloid leukemia during treatment with nilotinib

Author

David Sanford, Maria MacDonald, Michael Nicolle, and Anargyros Xenocostas

Subjects
chronic myeloid leukemia, tyrosine kinase inhibitors, adverse drug events, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

We report on a patient diagnosed with chronic myeloid leukemia (CML) who developed myasthenia gravis while on treatment with nilotinib. Autoimmune disease, including the development of myasthenia gravis, has been described in association with CML as well as the use of tyrosine kinase inhibitors. Second generation tyrosine kinase inhibitors are highly effective in the treatment of CML, although can result in adverse effects related to off-target kinase inhibition, and longer term reporting of adverse effects is required.

Published
2014
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2. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study

Author

James F Howard, Saskia Bresch, Angela Genge, Channa Hewamadduma, John Hinton, Yessar Hussain, Raul Juntas-Morales, Henry J Kaminski, Angelina Maniaol, Renato Mantegazza, Masayuki Masuda, Kumaraswamy Sivakumar, Marek Śmiłowski, Kimiaki Utsugisawa, Tuan Vu, Michael D Weiss, Małgorzata Zajda, Babak Boroojerdi, Melissa Brock, Guillemette de la Borderie, Petra W Duda, Romana Lowcock, Mark Vanderkelen, M Isabel Leite, Dylan Sembinelli, Jeanne Teitelbaum, Michael Nicolle, Emilien Bernard, Juliette Svahn, Marco Spinazzi, Tanya Stojkovic, Sophie Demeret, Nicolas Weiss, Loïc Le Guennec, Sihame Messai, Christine Tranchant, Aleksandra Nadaj-Pakleza, Jean-Baptiste Chanson, Muhtadi Suliman, Leila Zaidi, Celine Tard, Peggy Lecointe, Jana Zschüntzsch, Jens Schmidt, Stefanie Glaubitz, Rachel Zeng, Matthias Scholl, Markus Kowarik, Ulf Ziemann, Markus Krumbholz, Pascal Martin, Christoph Ruschil, Jutta Dünschede, Roswitha Kemmner, Natalie Rumpel, Benjamin Berger, Andreas Totzeck, Tim Hagenacker, Benjamin Stolte, Raffaele Iorio, Amelia Evoli, Silvia Falso, Carlo Antozzi, Rita Frangiamore, Fiammetta Vanoli, Elena Rinaldi, Kazushi Deguchi, Naoya Minami, Yuriko Nagane, Yasushi Suzuki, Sayaka Ishida, Shigeaki Suzuki, Jin Nakahara, Astushi Nagaoka, Shunsuke Yoshimura, Shingo Konno, Youko Tsuya, Akiyuki Uzawa, Tomoya Kubota, Masanori Takahashi, Tatsusada Okuno, Hiroyuki Murai, Nils Erik Gilhus, Marion Boldingh, Tone Hakvåg Rønning, Urszula Chyrchel-Paszkiewicz, Klaudiusz Kumor, Tomasz Zielinski, Krzysztof Banaszkiewicz, Michał Błaż, Agata Kłósek, Mariola Świderek-Matysiak, Andrzej Szczudlik, Aneta Paśko, Lech Szczechowski, Marta Banach, Jan Ilkowski, Solange Kapetanovic Garcia, Patricia Ortiz Bagan, Ana Belén Cánovas Segura, Joana Turon Sans, Nuria Vidal Fernandez, Elena Cortes Vicente, Patricia Rodrigo Armenteros, Mohammad Ashraghi, Ana Cavey, Liam Haslam, Anna Emery, Kore Liow, Sharon Yegiaian, Alexandru Barboi, Rosa Maria Vazquez, Joshua Lennon, Robert M Pascuzzi, Cynthia Bodkin, Sandra Guingrich, Adam Comer, Mark Bromberg, Teresa Janecki, Sami Saba, Marco Tellez, Bakri Elsheikh, Miriam Freimer, Sarah Heintzman, Raghav Govindarajan, Jeffrey Guptill, Janice M Massey, Vern Juel, Natalia Gonzalez, Ali A Habib, Tahseen Mozaffar, Manisha Korb, Namita Goyal, Hannah Machemehl, Georgios Manousakis, Jeffrey Allen, Emily Harper, Constantine Farmakidis, Lilli Saavedra, Mazen Dimachkie, Mamatha Pasnoor, Salma Akhter, Said Beydoun, Courtney McIlduff, Joan Nye, Bhaskar Roy, Bailey Munro Sheldon, Richard Nowak, Benjamin Barnes, Michael Rivner, Niraja Suresh, Jessica Shaw, Brittany Harvey, Lucy Lam, Nikki Thomas, Manisha Chopra, Rebecca E Traub, Sarah Jones, Mary Wagoner, Sejla Smajic, Radwa Aly, Jonathan Katz, Henry Chen, Robert G Miller, Liberty Jenkins, Shaida Khan, Bhupendra Khatri, Lisa Sershon, Pantelis Pavlakis, Shara Holzberg, Yuebing Li, Irys B Caristo, Robert Marquardt, Debbie Hastings, Jacob Rube, Robert P Lisak, Aparna Choudhury, Katherine Ruzhansky, Amit Sachdev, Susan Shin, Joan Bratton, Mary Fetter, Naya McKinnon, Jonathan McKinnon, Laura Sissons-Ross, Amos Sahu, and B Jane Distad

Subjects
Neurology (clinical)
Published
2023

3. Clinical Effects of the Self-administered Subcutaneous Complement Inhibitor Zilucoplan in Patients With Moderate to Severe Generalized Myasthenia Gravis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial

Author

James F, Howard, Richard J, Nowak, Gil I, Wolfe, Miriam L, Freimer, Tuan H, Vu, John L, Hinton, Michael, Benatar, Petra W, Duda, James E, MacDougall, Ramin, Farzaneh-Far, Henry J, Kaminski, Richard, Barohn, Mazen, Dimachkie, Mamatha, Pasnoor, Constantine, Farmakidis, Tina, Liu, Samantha, Colgan, Michael G, Benatar, Tulio, Bertorini, Rekha, Pillai, Robert, Henegar, Mark, Bromberg, Summer, Gibson, Teresa, Janecki, Miriam, Freimer, Bakri, Elsheikh, Paige, Matisak, Angela, Genge, Amanda, Guidon, William, David, Ali A, Habib, Veena, Mathew, Tahseen, Mozaffar, William, Hewitt, Deborah, Barnett, Patricia, Sullivan, Doreen, Ho, Rebecca E, Traub, Manisha, Chopra, Radwa, Aly, Elham, Bayat, Mohammad, Abu-Rub, Shaida, Khan, Dale, Lange, Shara, Holzberg, Bhupendra, Khatri, Emily, Lindman, Tayo, Olapo, Lisa M, Sershon, Robert P, Lisak, Evanthia, Bernitsas, Kelly, Jia, Rabia, Malik, Tiffany D, Lewis-Collins, Michael, Nicolle, Aditi, Sharma, Bhaskar, Roy, Joan, Nye, Michael, Pulley, Alan, Berger, Yasmeen, Shabbir, Amit, Sachdev, Kimberly, Patterson, Zaeem, Siddiqi, Mark, Sivak, Joan, Bratton, George, Small, Anem, Kohli, Mary, Fetter, Tuan, Vu, Lucy, Lam, Brittany, Harvey, Nicholas, Silvestri, Kara, Patrick, Karen, Zakalik, James, MacDougall, Angela, Pontius, and Michelle, Hoarty

Subjects
Male, medicine.medical_specialty, Randomization, Injections, Subcutaneous, Population, Phases of clinical research, Self Administration, Placebo, law.invention, 03 medical and health sciences, Complement inhibitor, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Myasthenia Gravis, medicine, Humans, 030212 general & internal medicine, education, education.field_of_study, business.industry, Complement C5, Middle Aged, Clinical trial, Complement Inactivating Agents, Tolerability, Female, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Importance Many patients with generalized myasthenia gravis (gMG) have substantial clinical disability, persistent disease burden, and adverse effects attributable to chronic immunosuppression. Therefore, there is a significant need for targeted, well-tolerated therapies with the potential to improve disease control and enhance quality of life. Objective To evaluate the clinical effects of zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor of complement component 5, in a broad population of patients with moderate to severe gMG. Design, Setting, and Participants This randomized, double-blind, placebo-controlled phase 2 clinical trial at 25 study sites across North America recruited participants between December 2017 and August 2018. Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)–positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history. Interventions Patients were randomized 1:1:1 to a daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan for 12 weeks. Main Outcomes and Measures The primary and key secondary end points were the change from baseline to week 12 in QMG and MG Activities of Daily Living scores, respectively. Significance testing was prespecified at a 1-sided α of .10. Safety and tolerability were also assessed. Results The study of 44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables. The mean age of patients across all 3 treatment groups ranged from 45.5 to 54.6 years and most patients were white (average proportions across 3 treatment groups: 78.6%-86.7%). Clinically meaningful and statistically significant improvements in primary and key secondary efficacy end points were observed. Zilucoplan at a dose of 0.3 mg/kg SC daily resulted in a mean reduction from baseline of 6.0 points in the QMG score (placebo-corrected change, –2.8;P = .05) and 3.4 points in the MG Activities of Daily Living score (placebo-corrected change, –2.3;P = .04). Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores. Outcomes for the 0.1-mg/kg SC daily dose were also statistically significant but slower in onset and less pronounced than with the 0.3-mg/kg dose. Rescue therapy (intravenous immunoglobulin or plasma exchange) was required in 3 of 15, 1 of 15, and 0 of 14 participants in the placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan arms, respectively. Zilucoplan was observed to have a favorable safety and tolerability profile. Conclusions and Relevance Zilucoplan yielded rapid, meaningful, and sustained improvements over 12 weeks in a broad population of patients with moderate to severe AChR-Ab–positive gMG. Near-complete complement inhibition appeared superior to submaximal inhibition. The observed safety and tolerability profile of zilucoplan was favorable. Trial Registration ClinicalTrials.gov Identifier:NCT03315130.

Published
2020

4. Paraneoplastic downbeat nystagmus

Author

Michael Nicolle, Jamie L. Steckley, Miguel Bussière, David A. Nicolle, and Amal Al-Khotani

Subjects
medicine.medical_specialty, Lymphatic metastasis, Fatal outcome, business.industry, General Medicine, Nystagmus, medicine.disease, Downbeat nystagmus, Ophthalmology, X ray computed, medicine, Carcinoma, Radiology, medicine.symptom, business
Published
2008

6. A population-based study of multiple sclerosis in twins

Author

George C. Ebers, Dennis E. Bulman, Adele D. Sadovnick, Donald W. Paty, Sharon Warren, Walter Hader, T. Jock Murray, T. Peter Seland, Pierre Duquette, Trevor Grey, Robert Nelson, Michael Nicolle, and Donald Brunet

Subjects
Male, Canada, Pathology, medicine.medical_specialty, Pediatrics, Magnetic Resonance Spectroscopy, Multiple Sclerosis, Dizygotic twin, Concordance, Large population, Disease, Dizygotic twins, Diseases in Twins, Twins, Dizygotic, medicine, Genetic predisposition, Humans, business.industry, Multiple sclerosis, Twins, Monozygotic, General Medicine, medicine.disease, Population based study, Female, Disease Susceptibility, Epidemiologic Methods, business
Abstract

Results from studies of twin concordance in multiple sclerosis have not conclusively differentiated between environmental and genetic factors that determine susceptibility to the disease. Published studies that have been based on case finding by public appeal have been characterized by difficulties in ascertainment. The data reported here are from a large population-based study of multiple sclerosis in twins, in which ascertainment has been relatively unbiased and the cooperation of patients nearly complete. A total of 5463 patients attending 10 multiple sclerosis clinics across Canada were surveyed. Twenty-seven monozygotic and 43 dizygotic twin pairs were identified, and the diagnosis of multiple sclerosis was verified by examination and laboratory investigation. Seven of 27 monozygotic pairs (25.9 percent) and 1 of 43 dizygotic pairs (2.3 percent) were concordant for multiple sclerosis. The concordance rate for 4582 nontwin siblings of patients at two multiple sclerosis clinics was 1.9 percent, closely paralleling the concordance rate in dizygotic twins. To the extent that the difference in concordance rates between monozygotic and dizygotic twins indicates genetic susceptibility, the results of this study show a major genetic component in susceptibility to multiple sclerosis.

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