L’Italien, Gilbert J.
Oikonomou, Evangelos K.
Khera, Rohan
Potashman, Michele H.
Beiner, Melissa W.
Maclaine, Grant D. H.
Schmahmann, Jeremy D.
Perlman, Susan
Coric, Vladimir
Clinical trials referenced in this document:
Documents that mention this clinical trial
Measurement Properties of the Friedreich Ataxia Rating Scale in Patients with Spinocerebellar Ataxia
https://doi.org/10.1007/s40120-024-00708-4
Video-Based Kinematic Analysis of Movement Quality in a Phase 3 Clinical Trial of Troriluzole in Adults with Spinocerebellar Ataxia: A Post Hoc Analysis
https://doi.org/10.1007/s40120-024-00625-6
Funding for this research was provided by:
Biohaven Pharmaceuticals, Inc.
Article History
Received: 9 February 2024
Accepted: 24 April 2024
First Online: 30 May 2024
Change Date: 8 June 2024
Change Type: Update
Change Details: The original online version of this article was revised to correct the digital features link.
Declarations
:
: Evangelos Oikonomou receives support from the National Heart, Lung, and Blood Institute of the National Institutes of Health (under award 1F32HL170592) outside the submitted work. He is an academic co-founder of Evidence2Health LLC, a co-inventor in patent applications (US17/720,068, 63/177,117, 63/580,137, 63/606,203, WO2018078395A1, WO2020058713A1) and has been an ad hoc consultant for Caristo Diagnostics Ltd. Rohan Khera is an Associate Editor of JAMA. He receives support from the National Heart, Lung, and Blood Institute of the National Institutes of Health (under award K23HL153775) and the Doris Duke Charitable Foundation (under award, 2022060) outside the submitted work. He also receives research support, through Yale, from Bristol-Myers Squibb and Novo Nordisk. He is a coinventor of U.S. Provisional Patent Applications 63/177,117, 63/428,569, 63/346,610, 63/484,426, 63/508,315, 63/580,137 and 63/606,203, and an academic co-founder of Evidence2Health, LLC and ENSIGHT-AI, Inc. Jeremy Schmahmann has served on the editorial board for The Cerebellum, Editorial Board,1999. Consultancy: Biohaven Pharmaceuticals. Site PI: Biohaven clinical Trials in ataxia and multiple system atrophy. Research Support, Commercial Entities: Biohaven Pharma support of clinical trials. Research Support, Academic Entities: National Ataxia Foundation. Research Support, Foundations and Societies: National Ataxia Foundation, 2019, PI License fee payments, Technology or Inventions: Brief Ataxia Rating Scale (BARS), and Brief Ataxia Rating Scale revised (BARS2). Copyright held by The General Hospital Corporation. Cerebellar Cognitive Affective/Schmahmann syndrome Scale. Copyright held by The General Hospital Corporation. Patient-Reported Outcome Measure of Ataxia. Copyright held by The General Hospital Corporation. Cerebellar Neuropsychiatric Rating Scale. Copyright held by The General Hospital Corporation. Susan Perlman has nothing to disclose. Gilbert L’Italien, Michele Potashman, Melissa Beiner, Grant Maclaine and Vladimir Coric are employed by and own stock and stock options in Biohaven, Ltd.
: This study was conducted in accordance with Good Clinical Practice, as defined by the International Conference on Harmonization; the Helsinki Declaration of 1964; and in accordance with the ethical principles underlying European Union Directive 2001/20/EC and the US Code of Federal Regulations, Title 21, Part 50 (21CFR50). The study was approved by all participating institutions. The main ethics committee for the study was Advarra IRB of 6940 Columbia Gateway Drive, Suite 110, Columbia, MD 21046, USA. Full details of participating institutions and the ethics committees or institutional review boards which approved the study are provided in the supplementary materials. Participants in the original clinical trial signed informed consent which included information that the trial results might be published; for this post hoc analysis, no separate informed consent was obtained.