VIGOR-ALS
Research type
Research Study
Full title
A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031)
IRAS ID
213235
Contact name
Connie Sweeney
Contact email
Sponsor organisation
Cytokinetics, Inc.
Eudract number
2016-002629-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, days
Research summary
The CY 4033 study is a Phase 3 open-label extension study of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS) who have completed CY 4031, a randomized, double blind placebo controlled study of tirasemtiv in ALS patients. Tirasemtiv is being investigated as a potential new therapy for slowing progression of muscle weakness including muscles related to breathing and overall physical function. Tirasemtiv is an investigational product and has not been approved for use in any country. The symptoms of this disease may include extremity muscle weakness accompanied by twitching of the muscles, difficulty breathing, speaking, chewing or swallowing, along with weight loss. ALS is a relentlessly progressive fatal disease for which there is no current cure.
Approximately 350 participants will take part in this study, at 80 sites throughout the United States, Canada and Europe.Cytokinetics Inc. is sponsoring this clinical trial.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0119
Date of REC Opinion
5 Jun 2017
REC opinion
Further Information Favourable Opinion