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Skeletal Muscle Troponin Activator
A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) (COURAGE-ALS Trial)
Phase 3
Waitlist Available
Research Sponsored by Cytokinetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights
Pivotal Trial
Summary
This trial is testing reldesemtiv, a drug that may help improve muscle function, in patients aged 18 to 80 with ALS. The goal is to see if it can help them move more easily and stay stronger for longer. Reldesemtiv was previously tested in patients with ALS but did not show significant improvement.
Eligible Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Amyotrophic Lateral Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effect of Reldesemtiv Versus Placebo on Functional Outcomes in Amyotrophic Lateral Sclerosis (ALS)
Secondary study objectives
Effect of Reldesemtiv Versus Placebo on Combined Functional and Survival Outcomes in Amyotrophic Lateral Sclerosis (ALS)
Effect of Reldesemtiv Versus Placebo on Handgrip Strength
Effect of Reldesemtiv Versus Placebo on Quality of Life
+1 moreSide effects data
From 2019 Phase 2 trial • 458 Patients • NCT0316089814%
Headache
13%
Fatigue
11%
Diarrhoea
9%
Nausea
7%
Dizziness
7%
Contusion
7%
Skin abrasion
7%
Arthralgia
6%
Upper respiratory tract infection
6%
Cystatin C increased
6%
Constipation
5%
Viral upper respiratory tract infection
5%
Muscle spasms
5%
Post-traumatic pain
5%
Glomerular filtration rate decreased
3%
Urinary tract infection
3%
Decreased appetite
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Dysphagia
2%
Dry mouth
1%
Joint dislocation
1%
Oesophagitis
1%
Appendicitis
1%
Muscle contractions involuntary
1%
Dyspnoea
1%
Dehydration
1%
Weight decreased
1%
Pruritus
1%
Pain
1%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Reldesemtiv 150 mg Twice Daily
Reldesemtiv 300 mg Twice Daily
Reldesemtiv 450 mg Twice Daily
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Reldesemtiv Group, Double-Blind PeriodExperimental Treatment1 Intervention
Participants in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Group II: Early Start Group, Active Drug PeriodExperimental Treatment1 Intervention
Participants in this arm were those who received reldesemtiv in the double-blind and active drug periods. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Group III: Delayed Start Group, Active Drug PeriodExperimental Treatment1 Intervention
Participants in this arm were those who received placebo in the double-blind period and reldesemtiv in the active drug period. Participants take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48. Patients who were down-titrated for any reason during the 24 weeks of blinded dosing take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48.
Group IV: Placebo Group, Double-Blind PeriodPlacebo Group1 Intervention
Participants in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reldesemtiv
2017
Completed Phase 2
~510
Find a Location
Who is running the clinical trial?
CytokineticsLead Sponsor
41 Previous Clinical Trials
15,145 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
2,407 Patients Enrolled for Amyotrophic Lateral Sclerosis
Cytokinetics, MDStudy DirectorCytokinetics
5 Previous Clinical Trials
1,373 Total Patients Enrolled