COURAGE: Phase III, multicentre, double-blind, randomised, placebo-controlled study to assess the effect and safety of Reldesemtiv in patients with Amyotrophic Lateral Sclerosis (ALS).
This phase III study is sponsored by Cytokinetics, INC.
Patients with ALS who are between 18 and 80 years old, have been ill for less than 24 months, have a lung function (SVC) of ≥ 65% and have a score of 44 or less on the ALS-FRS-R scale may be eligible to participate in this study. Study medication must be taken by mouth and must not be crushed
Reldesemtiv is being investigated as a possible new treatment to improve muscle function.
In the first phase, two in three participants will receive two tablets of reldesemtiv twice daily and one in three will receive placebo (these are tablets with no active ingredient). Allocation into the groups will be random. Neither the patient nor the researcher can choose which treatment group someone is assigned to. This first part lasts for 24 weeks. This is followed by a second part of the study, in which all participants will be administered reldesemtiv.
This study will involve about 555 participants around the world.
Interested, or would you like further information? Contact us at onderzoek@als.be
More information on this study can be found at: https://clinicaltrials.gov/ct2/show/NCT04944784
