Search

Your search keyword '"Bunte, Tommy"' showing total 23 results
Start Over Author "Bunte, Tommy"
23 results on '"Bunte, Tommy"'

1. Safety and efficacy of arimoclomol in patients with early amyotrophic lateral sclerosis (ORARIALS-01): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial

Author

Granit, Volkan, Steele, Julie, Levy, Wendy, Paredes, Maria Elena, Hernandez, Jessica, Bilsker, Martin, Szacka, Katarzyna, Ronert, Adam, Jablońska, Dorota, Łuczak, Alina Zuzanna, Chaverri, Delia, Janse van Mantgem, Mark R, Bunte, Tommy M, Broere, Bianca, de Fockert, Arianne, Sanchez-Tejerina, Daniel, Landabaso, Carmen, Calvo, Andrea, Moglia, Cristina, Manera, Umberto, Canosa, Antonio, Vasta, Rosario, Salamone, Paolina, Fuda, Giuseppe, DeMarco, Giovanni, Casale, Federico, ME Forsberg, Karin, Winroth, Ivar, Almgren Stenberg, Erica, Holmgren, Monica, Amador, Maria del Mar, Lenglet, Timothee, Querin, Giorgia, Coudoin, Sylvie, Pavlakis, Pantelis, Holzberg, Shara, Sideri, Riccardo, Marinou, Kalliopi, Czarnecki, Maciej, Ługiewicz, Renata, Biel-Czarnecka, Marta, Boczkowska, Marcelina, Schotte, Caroline, Vynckier, Jan, Van Daele, Sien, Claeys, Thomas, Delmotte, Koen, Swinnen, Bart, Serrien, Anouk, D'Hondt, Ann, Lamaire, Nikita, Debien, Elisa, Jones, Sarah, Vachon, Chris, Grogan, James, Solorzano, Guillermo, Crowell, Allison, Rakocevic, Goran, Wagoner, Mary, Alma, Osmanovic, Flavia, Wiehler, Sonja, Körner, Olivia, Schreiber-Katz, Camilla, Wohnrade, Anastasia, Sarikidi, Carola, Kassebaum, Chantal, Fischer, Adamo, Ashley, Turcotte, Nicole, Duncan, Jessie, Turner, Ivone, Elman, Lauren, Massie, Rami, Berube, Maxime, Saunders, Natalie, Salmon, Kristiana, Foucher, Juliette, Agessandro, Abrahao, Shirley, Pham, Jahan, Mookshah, Phung, Liane, Statland, Jeffrey, Jawdat, Omar, Dimachkie, Mazen, Pasnoor, Mamatha, Farmakidis, Constantine, Heim, Andrew, Lillig, Katie, Lackey, Alyssa, Weber, Markus, Kurz, Martina, Levine, Todd, Benatar, Michael, Hansen, Thomas, Rom, Dror, Geist, Marie A, Blaettler, Thomas, Camu, William, Kuzma-Kozakiewicz, Magdalena, van den Berg, Leonard H, Morales, Raul Juntas, Chio, Adriano, Andersen, Peter M, Pradat, Pierre-Francois, Lange, Dale, Van Damme, Philip, Mora, Gabriele, Grudniak, Mariusz, Elliott, Matthew, Petri, Susanne, Olney, Nicholas, Ladha, Shafeeq, Goyal, Namita A, Meyer, Thomas, Hanna, Michael G, Quinn, Colin, Genge, Angela, Zinman, Lorne, Jabari, Duaa, Shoesmith, Christen, Ludolph, Albert C, Neuwirth, Christoph, Nations, Sharon, Shefner, Jeremy M, Turner, Martin R, Wuu, Joanne, Bennett, Richard, Dang, Hoang, and Sundgreen, Claus

Published
2024
Full Text
View/download PDF

2. REVEALS—a longitudinal cohort study of multifaceted respiratory assessment in ALS.

Author

Rooney, James, Murray, Deirdre, Meldrum, Dara, Al-Chalabi, Ammar, Bunte, Tommy, Chiwera, Theresa, Choudhury, Mutahhara, Chio, Adriano, Fenton, Lauren, Fortune, Jennifer, Maidment, Lindsay, Manera, Umberto, McDermott, Christopher J., Meyjes, Myrte, Tattersall, Rachel, Torrieri, Maria Claudia, Van Damme, Philip, Vanderlinden, Elien, Wood, Claire, and van den Berg, Leonard H.

Subjects
AMYOTROPHIC lateral sclerosis, RANDOM effects model, RESPIRATORY measurements, VITAL capacity (Respiration), RESPIRATORY diseases, COUGH
Abstract

Objective: To systematically assess decline in respiratory measures in amyotrophic lateral sclerosis (ALS) and to examine the impact of sex, disease onset type and baseline morbidity on progression. Methods: The REVEALS study (Registry of Endpoints and Validated Experiences in ALS) was conducted between April 2018 and February 2021 in six European ALS centers. Slow and forced vital capacity (S/FVC), sniff nasal inspiratory pressure (SNIP), peak cough flow, amyotrophic lateral sclerosis functional rating scale-revised (ALSFRS-R), and respiratory morbidity were collected. Data were analyzed using a Bayesian multiple outcomes random effects model. Results: Two hundred and eighty participants had a median of three assessments (IQR 2.0, 5.0) over a median of 8 months (IQR 2.3, 14.1). There were 974 data collection timepoints. Differences in respiratory measures and rates of decline between disease-onset and sex subgroups were identified. Females had lower scores in all respiratory measures and females with bulbar onset ALS had faster decline compared with other sub-groups. These differences were not detected by the ALSFRS-r respiratory subscale. Dyspnea, orthopnea, and a higher King's stage at baseline were associated with lower respiratory scores throughout follow-up, while having a regular productive cough at baseline was associated with lower peak cough flow scores. Conclusion: Respiratory function declines more quickly in females with ALS compared with males when measured by FVC, SVC, SNIP, or PCF, but not the ALSFRS-R respiratory sub-score. Higher baseline King's staging and the presence of clinical respiratory symptoms at baseline were associated with worse respiratory function. The ALSFRS-R respiratory sub-score is poorly correlated with objective respiratory measurements. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

3. The ALSFRS-R Summit: a global call to action on the use of the ALSFRS-R in ALS clinical trials

Author

Projectafdeling ALS, Brain, ALS Trial team, Neurologen, Genge, Angela, Cedarbaum, Jesse M., Shefner, Jeremy, Chio, Adriano, Al-Chalabi, Ammar, Van Damme, Philip, McDermott, Chris, Glass, Jonathan, Berry, James, van Eijk, Ruben P.A., Fournier, Christina, Grosskreutz, Julian, Andrews, Jinsy, Bertone, Vanessa, Bunte, Tommy M., Couillard, Mathias, Cummings, Cathy, Kittle, Gale, Polzer, John, Salmon, Kristiana, Straub, Corey, van den Berg, Leonard H., Projectafdeling ALS, Brain, ALS Trial team, Neurologen, Genge, Angela, Cedarbaum, Jesse M., Shefner, Jeremy, Chio, Adriano, Al-Chalabi, Ammar, Van Damme, Philip, McDermott, Chris, Glass, Jonathan, Berry, James, van Eijk, Ruben P.A., Fournier, Christina, Grosskreutz, Julian, Andrews, Jinsy, Bertone, Vanessa, Bunte, Tommy M., Couillard, Mathias, Cummings, Cathy, Kittle, Gale, Polzer, John, Salmon, Kristiana, Straub, Corey, and van den Berg, Leonard H.

Published
2024

5. The ALSFRS-R Summit: a global call to action on the use of the ALSFRS-R in ALS clinical trials.

Author

Genge, Angela, Cedarbaum, Jesse M., Shefner, Jeremy, Chio, Adriano, Al-Chalabi, Ammar, Van Damme, Philip, McDermott, Chris, Glass, Jonathan, Berry, James, van Eijk, Ruben P.A., Fournier, Christina, Grosskreutz, Julian, Andrews, Jinsy, Bertone, Vanessa, Bunte, Tommy M, Couillard, Mathias, Cummings, Cathy, Kittle, Gale, Polzer, John, and Salmon, Kristiana

Subjects
CLINICAL trials, AMYOTROPHIC lateral sclerosis, EXPERIMENTAL design
Abstract

The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) was developed more than 25 years ago as an instrument to monitor functional change over time in patients with ALS. It has since been revised and extended to meet the needs of high data quality in ALS trials (ALSFRS-R), however a full re-validation of the scale was not completed. Despite this, the scale has remained a primary outcome measure in clinical trials. We convened a group of clinical trialists to discuss and explore opportunities to improve the scale and propose alternative measures. In this meeting report, we present a call to action on the use of the ALSFRS-Revised scale in clinical trials, focusing on the need for (1) harmonization of the ALSFRS-R administration globally, (2) alignment on a set of recommendations for clinical trial design and statistical analysis plans (SAPs), and (3) use of additional outcome measures. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

8. Development of a Rasch-Built Amyotrophic Lateral Sclerosis Impairment Multidomain Scale to Measure Disease Progression in ALS

Author

de Jongh, Adriaan D., primary, van Eijk, Ruben P.A., additional, Bakker, Leonhard A., additional, Bunte, Tommy M., additional, Beelen, Anita, additional, van der Meijden, Conny, additional, van Es, Michael A., additional, Visser-Meily, Johanna M.A., additional, Kruitwagen, Esther T., additional, Veldink, Jan H., additional, and van den Berg, Leonard H., additional

Published
2023
Full Text
View/download PDF

9. A randomized, double‐blind, placebo‐controlled, phase 2 study to assess safety, tolerability and efficacy of RT001 in patients with amyotrophic lateral sclerosis.

Author

Weemering, Daphne N., primary, Midei, Mark, additional, Milner, Peter, additional, Gopalakrishnan, Vidhya, additional, Kumar, Anil, additional, Dannenberg, Andrew J., additional, Bunte, Tommy M., additional, Foucher, Juliette, additional, Ingre, Caroline, additional, Ķēniņa, Viktorija, additional, Rallmann, Karin, additional, van den Berg, Leonard H., additional, and van Eijk, Ruben P. A., additional

Published
2023
Full Text
View/download PDF

10. Harmonized standard operating procedures for administering the ALS functional rating scale-revised.

Author

Shefner, Jeremy M., Bunte, Tommy, Kittle, Gale, Genge, Angela, and van den Berg, Leonard H

Subjects
*STANDARD operating procedure, *CLINICAL trials
Abstract

The ALS Functional Rating Scale-Revised is the most commonly used primary outcome measure in current ALS clinical trials. While rigorous training and certification is generally recognized as critical to reliable performance, differences have existed between training in the two groups responsible for most training in ALS outcome measures. We present a harmonized standard operating procedure which is intended to further reduce response variability by the use of identical training in North America and Europe. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

11. A randomized, double-blind, placebo-controlled phase 2 study to assess safety, tolerability, and efficacy of RT001 in patients with amyotrophic lateral sclerosis

Author

Projectafdeling ALS, Neurologen, Brain, Regenerative Medicine and Stem Cells, Weemering, Daphne N, Midei, Mark, Milner, Peter, Gopalakrishnan, Vidhya, Kumar, Anil, Dannenberg, Andrew J, Bunte, Tommy M, Foucher, Juliette, Ingre, Caroline, Ķēniņa, Viktorija, Rallmann, Karin, van den Berg, Leonard H, van Eijk, Ruben P A, Projectafdeling ALS, Neurologen, Brain, Regenerative Medicine and Stem Cells, Weemering, Daphne N, Midei, Mark, Milner, Peter, Gopalakrishnan, Vidhya, Kumar, Anil, Dannenberg, Andrew J, Bunte, Tommy M, Foucher, Juliette, Ingre, Caroline, Ķēniņa, Viktorija, Rallmann, Karin, van den Berg, Leonard H, and van Eijk, Ruben P A

Published
2023

12. Development of a Rasch-Built Amyotrophic Lateral Sclerosis Impairment Multidomain Scale to Measure Disease Progression in ALS

Author

Projectafdeling ALS, Brain, Neurologen, Revalidatiegeneeskunde Onderzoek, Child Health, Neuromuscular Disorders, RF&S Revalidatie, Fysiotherapie & Sport, Revalidatie Medisch Volwassenen, Circulatory Health, Genetic Risks, Regenerative Medicine and Stem Cells, de Jongh, Adriaan D, van Eijk, Ruben P A, Bakker, Leonhard A, Bunte, Tommy M, Beelen, Anita, van der Meijden, Conny, van Es, Michael A, Visser-Meily, Johanna, Kruitwagen, Esther T, Veldink, Jan H, van den Berg, Leonard H, Projectafdeling ALS, Brain, Neurologen, Revalidatiegeneeskunde Onderzoek, Child Health, Neuromuscular Disorders, RF&S Revalidatie, Fysiotherapie & Sport, Revalidatie Medisch Volwassenen, Circulatory Health, Genetic Risks, Regenerative Medicine and Stem Cells, de Jongh, Adriaan D, van Eijk, Ruben P A, Bakker, Leonhard A, Bunte, Tommy M, Beelen, Anita, van der Meijden, Conny, van Es, Michael A, Visser-Meily, Johanna, Kruitwagen, Esther T, Veldink, Jan H, and van den Berg, Leonard H

Published
2023

13. The Integrated Stress Response Is Modulated by eIF2B Agonist DNL343: Results From Phase 1 Healthy Subject and Phase 1b ALS Patient Studies. (P8-8.010)

Author

Sun, Linus, primary, Tsai, Richard, additional, Yulyaningsih, Ernie, additional, Fanok, Melania, additional, Vissers, Maurits, additional, Heuberger, Jules, additional, Flores, Brittany, additional, Huang, Fen, additional, Kane, Lesley, additional, Cohen, Isaac, additional, Dhuria, Shyeilla, additional, Fang, Meng, additional, Estrada, Anthony, additional, Osipov, Maksim, additional, Willman-Yoswa, Brent, additional, Maciuca, Romeo, additional, Dobbins, Sarah, additional, Chau, Ronnie, additional, Earr, Timothy, additional, Nguyen, Hoang, additional, Lopez, Isabel, additional, Scearce-Levie, Kimberly, additional, Bunte, Tommy, additional, Van den Berg, Leonard, additional, Ho, Carole, additional, Groeneveld, Geert-Jan, additional, and Troyer, Matthew, additional

Published
2023
Full Text
View/download PDF

14. International network for ALS research and care (INARC).

Author

Foucher, Juliette, Bunte, Tommy M., Bertone, Vanessa, Verschoor, Romy L., Couillard, Mathias, Straub, Corey, Genge, Angela, Ingre, Caroline, and van den Berg, Leonard H.

Subjects
*AMYOTROPHIC lateral sclerosis, *PROBLEM solving, *INTERNATIONAL cooperation, *RESEARCH teams, *PHYSICIANS
Abstract

The International Network for Amyotrophic Lateral Sclerosis (ALS) Research and Care (INARC) was founded in 2022. INARC's main goals are to offer a platform dedicated to staff members for ALS clinics and research teams who are not physicians. By nurturing experience and expertise exchanges to improve problem solving skills, the ultimate goal is to increase the standard ALS care and research. This brief report aims to describe the formation of INARC, the 2023 INARC meeting, as well as to report topics discussed, lessons learned and challenges raised by INARC members. [ABSTRACT FROM AUTHOR]

Published
2024
Full Text
View/download PDF

15. Using the ALSFRS-R in multicentre clinical trials for amyotrophic lateral sclerosis: potential limitations in current standard operating procedures

Author

Revalidatiegeneeskunde Onderzoek, Brain, Neurologen, Child Health, RF&S Revalidatie, Fysiotherapie & Sport, Revalidatie Medisch Volwassenen, Circulatory Health, Projectafdeling ALS, Regenerative Medicine and Stem Cells, Bakers, Jaap N E, de Jongh, Adriaan D, Bunte, Tommy M, Kendall, Lindsay, Han, Steve S, Epstein, Noam, Lavrov, Arseniy, Beelen, Anita, Visser-Meily, Johanna M A, van den Berg, Leonard H, van Eijk, Ruben P A, Revalidatiegeneeskunde Onderzoek, Brain, Neurologen, Child Health, RF&S Revalidatie, Fysiotherapie & Sport, Revalidatie Medisch Volwassenen, Circulatory Health, Projectafdeling ALS, Regenerative Medicine and Stem Cells, Bakers, Jaap N E, de Jongh, Adriaan D, Bunte, Tommy M, Kendall, Lindsay, Han, Steve S, Epstein, Noam, Lavrov, Arseniy, Beelen, Anita, Visser-Meily, Johanna M A, van den Berg, Leonard H, and van Eijk, Ruben P A

Published
2022

16. Using the ALSFRS-R in multicentre clinical trials for amyotrophic lateral sclerosis: potential limitations in current standard operating procedures

Author

Bakers, Jaap N.E., primary, de Jongh, Adriaan D., additional, Bunte, Tommy M., additional, Kendall, Lindsay, additional, Han, Steve S., additional, Epstein, Noam, additional, Lavrov, Arseniy, additional, Beelen, Anita, additional, Visser-Meily, Johanna M.A., additional, van den Berg, Leonard H., additional, and van Eijk, Ruben P. A., additional

Published
2021
Full Text
View/download PDF

17. Using the ALSFRS-R in multicentre clinical trials for amyotrophic lateral sclerosis: potential limitations in current standard operating procedures.

Author

Bakers, Jaap N.E., de Jongh, Adriaan D., Bunte, Tommy M., Kendall, Lindsay, Han, Steve S., Epstein, Noam, Lavrov, Arseniy, Beelen, Anita, Visser-Meily, Johanna M.A., van den Berg, Leonard H., and van Eijk, Ruben P. A.

Subjects
AMYOTROPHIC lateral sclerosis, STANDARD operating procedure, CLINICAL trials
Abstract

Objective: Uniform data collection is fundamental for multicentre clinical trials. We aim to determine the variability, between ALS trial centers, in the prevalence of unexpected or implausible improvements in the revised ALS functional rating scale (ALSFRS-R) score, and its associations with individual patient and item characteristics. Methods: We used data from two multicentre studies to estimate the prevalence of an unexpected increase or implausible improvement in the ALSFRS-R score, defined as an increase of 5 points or more between two consecutive, monthly visits. For each patient with a 5-point or more increase, we evaluated the individual contribution of each ALSFRS-R item. Results: Longitudinal ALSFRS-R scores, originating from 114 trial centers enrolling a total of 1,240 patients, were analyzed. A 5-point or more increase in ALSFRS-R total score was found in 151 (12.2%) patients, with prevalence per study center ranging from 0% to 83%. Bulbar onset, faster disease progression at enrollment, and a lower ALSFRS-R score at baseline were associated with a sudden 5-point or more increase in the ALSFRS-R total score. ALSFRS-R items 2 (saliva), 9 (stairs), 10 (dyspnea), and 11 (orthopnea) were the primary drivers when a 5-point or more increase occurred. Conclusions: Sudden 5-point or more increases in ALSFRS-R total scores between two consecutive visits are relatively common. These sudden increases were not found to occur with equal frequency in trial centers; which underscores the need for amending existing standard operating procedures toward a universal version and monitoring of data quality during the study, in multicentre research. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

18. Correlations between measures of ALS respiratory function: is there an alternative to FVC?

Author

Murray, Deirdre, primary, Rooney, James, additional, Al-Chalabi, Amar, additional, Bunte, Tommy, additional, Chiwera, Theresa, additional, Choudhury, Mutahhara, additional, Chio, Adriano, additional, Fenton, Lauren, additional, Fortune, Jennifer, additional, Maidment, Lindsay, additional, Manera, Umberto, additional, Mcdermott, Chris, additional, Meldrum, Dara, additional, Meyjes, Myrte, additional, Tattersall, Rachel, additional, Torrieri, Maria Claudia, additional, Van Damme, Philip, additional, Vanderlinden, Elien, additional, Wood, Claire, additional, Van Den Berg, Leonard H., additional, and Hardiman, Orla, additional

Published
2021
Full Text
View/download PDF

19. Correlations between measures of ALS respiratory function: is there an alternative to FVC?

Author

Projectafdeling ALS, Brain, Neurologen, Regenerative Medicine and Stem Cells, Murray, Deirdre, Rooney, James, Al-Chalabi, Amar, Bunte, Tommy, Chiwera, Theresa, Choudhury, Mutahhara, Chio, Adriano, Fenton, Lauren, Fortune, Jennifer, Maidment, Lindsay, Manera, Umberto, Mcdermott, Chris, Meldrum, Dara, Meyjes, Myrte, Tattersall, Rachel, Torrieri, Maria Claudia, Van Damme, Philip, Vanderlinden, Elien, Wood, Claire, Van Den Berg, Leonard H, Hardiman, Orla, Projectafdeling ALS, Brain, Neurologen, Regenerative Medicine and Stem Cells, Murray, Deirdre, Rooney, James, Al-Chalabi, Amar, Bunte, Tommy, Chiwera, Theresa, Choudhury, Mutahhara, Chio, Adriano, Fenton, Lauren, Fortune, Jennifer, Maidment, Lindsay, Manera, Umberto, Mcdermott, Chris, Meldrum, Dara, Meyjes, Myrte, Tattersall, Rachel, Torrieri, Maria Claudia, Van Damme, Philip, Vanderlinden, Elien, Wood, Claire, Van Den Berg, Leonard H, and Hardiman, Orla

Published
2021

21. A placebo-controlled trial to investigate the safety and efficacy of Penicillin G/Hydrocortisone in patients with ALS (PHALS trial)

Author

ZL Neuromusculaire Ziekten Medisch, Brain, Projectafdeling ALS, Neurologen, Regenerative Medicine and Stem Cells, Van Es, Michael A, Van Eijk, Ruben P A, Bunte, Tommy M, Van Den Berg, Leonard H, ZL Neuromusculaire Ziekten Medisch, Brain, Projectafdeling ALS, Neurologen, Regenerative Medicine and Stem Cells, Van Es, Michael A, Van Eijk, Ruben P A, Bunte, Tommy M, and Van Den Berg, Leonard H

Published
2020

23. Accelerometry for remote monitoring of physical activity in amyotrophic lateral sclerosis: a longitudinal cohort study

Author

Projectafdeling ALS, Brain, RF&S Team 1 Medisch, Neurologen, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, Child Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, ZL Neuromusculaire Ziekten Medisch, Regenerative Medicine and Stem Cells, van Eijk, Ruben P A, Bakers, Jaap N E, Bunte, Tommy M, de Fockert, Arianne J, Eijkemans, Marinus J C, van den Berg, Leonard H, Projectafdeling ALS, Brain, RF&S Team 1 Medisch, Neurologen, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, Child Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, ZL Neuromusculaire Ziekten Medisch, Regenerative Medicine and Stem Cells, van Eijk, Ruben P A, Bakers, Jaap N E, Bunte, Tommy M, de Fockert, Arianne J, Eijkemans, Marinus J C, and van den Berg, Leonard H

Published
2019

Catalog

Books, media, physical & digital resources
See catalog results