COURAGE-ALS

• Research type

  Research Study

• Full title

  A Phase 3, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS)

• IRAS ID

  290001

• Contact name

  Ammar Al-Chalabi

• Contact email

  ammar.al-chalabi@kcl.ac.uk

• Sponsor organisation

  Cytokinetics, Inc

• Eudract number

  2020-004040-29

• Clinicaltrials.gov Identifier

  NCT05442775

• Clinicaltrials.gov Identifier

  IND (Investigational new drug), 134567

• Duration of Study in the UK

  2 years, 2 months, 1 days

• Research summary

  This is a Phase 3, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS). 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 efficacy and safety of reldesemtiv. Additionally, this research study will evaluate the pharmacokinetics (PK) of reldesemtiv. We will screen around 740 patients with ALS and approximately 555 of these patients will be enrolled. The study will be conducted at approximately 80 sites globally (North America, Canada, Europe and Australia) and will be funded by Cytokinetics, Inc.
  Patients with ALS will be asked to participate in this trial and patients would be on the study for around 52 weeks including the follow-up period, the full dosing period will be a maximum of 48 weeks. This study is split into two parts, part 1 last 24 weeks will have patients randomised 2:1 (2 patients receiving reldesemtiv and 1 patient receiving placebo), part 2 will last another 24 weeks where all patients will receive reldesemtiv.
  During this trial there will be a combination of home health care visits and hospital visits, this is in place to reduce the burden to patients and also reduce risk of COVID-19.
  The patients will be having to complete multiple assessments for research purposes these including Forced Vital Capacity (FVC), blood sampling, physical examinations, neurological examinations, electrocardiograms, vital signs, muscle strength testing and maximum handgrip testing, questionnaire completion and optionally, genetic testing.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  21/LO/0391

• Date of REC Opinion

  14 Jul 2021

• REC opinion

  Further Information Favourable Opinion