Phase 3

COURAGE-ALS Trial

Industry trial

In the COURAGE-ALS study, we are investigating the efficacy and safety of the drug ‘reldesemtiv’ for the treatment of ALS. This clinical trial is sponsored by Cytokinetics.

Reldesemtiv in people with ALS

Reldesemtiv was developed by Cytokinetics in order to counteract the decline in muscle function. In a phase 2 study, the drug was tested in people with ALS for a 12 week period. The current study is testing its effectiveness in the longer term and in a larger group of people.

Study design

This phase 3 study is a double-blind, randomised, placebo-controlled study. This means we are comparing the effects of reldesemtiv against the effects of a placebo. A placebo is a drug without an active ingredient, a ‘fake drug’.

Both reldesemtiv and the placebo should be taken as a daily capsule. Participants will be randomly allocated either the placebo or reldesemtiv. Neither the participant nor the research team will know whether the participant is receiving the placebo or reldesemtiv.

The entire study will last 48 weeks. Participants will be examined in hospital 8 times during this period. Participants will receive either reldesemtiv or a placebo during the first 24 weeks.  All participants will receive reldesemtiv during the second 24 weeks.

Entry criteria

The main entry criteria for participating in this study are as follows:

  • Participants must be between 18 and 80 years old
  • Disease onset within the last 24 months
  • The participant’s lung function is at least 65%, without the use of a ventilator
  • When using Riluzole: a stable dose of ≥30 days prior to participation
  • Participants are not pregnant or breastfeeding
  • Participants haven’t participated in another clinical trial in the past 30 days

Note: This list is not exhaustive, but these are the main criteria.

Participants can continue their treatment with Riluzole for the entire study duration. Participants can also participate in the study if they don’t take Riluzole.

The study is currently being conducted in the following countries: The Netherlands, Ireland and Spain.

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