COURAGE-ALS OLE
Research type
Research Study
Full title
A Phase 3, Open-Label Extension of COURAGE-ALS(CY 5031)
IRAS ID
1006770
Contact name
Bonnie Charpentier
Contact email
Sponsor organisation
Cytokinetics Inc
Eudract number
2021-004727-33
Clinicaltrials.gov Identifier
Research summary
Reldesemtiv is being investigated as a potential new therapy for the improvement of skeletal muscle function in conditions associated with muscle weakness or fatigue such as Amyotrophic Lateral Sclerosis (“ALS”). The main purpose of this research study is to evaluate the safety and tolerability of reldesemtiv. By safety, we mean the collection of information about whether there are any negative symptoms and/or side effects that may result from taking reldesemtiv. By tolerability, we mean how well a patient tolerates the unexpected medical problems that may arise while taking the study drug.
Patients will participate in the study will be about 52 weeks (week 48 weeks of dosing, 4 weeks for follow-up). During this time, there will be up to six clinic visits and eight telephone visits.
Patients who have ALS and you have completed dosing in the COURAGE-ALS study (CY 5031) will be able to participate in this trial.
This trial will take place in a hospital setting.
Participants will have medical history reviewed, physical and neurological examinations, vital signs, blood sampling, pregnancy testing (if applicable), interview with ALSFRS-r (This is a questionnaire-based scale that measures and tracks changes in 12 aspects of a person’s physical function over time. It will be verbally administered by a trained evaluator who may ask additional questions to clarify your responses. ), Review of patient use of breathing devices, wheelchairs, feeding tubes, and speech aids and reviews of adverse events and concomitant medication.
REC name
London - South East Research Ethics Committee
REC reference
22/LO/0908
Date of REC Opinion
30 Mar 2023
REC opinion
Further Information Favourable Opinion