← Back to Search

Skeletal Muscle Troponin Activator

Reldesemtiv for Amyotrophic Lateral Sclerosis (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 24 weeks
Awards & highlights

COURAGE-ALS Trial Summary

This trial will study whether reldesemtiv can improve quality of life for people with ALS.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

COURAGE-ALS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of reldesemtiv versus placebo on functional outcomes in ALS
Secondary outcome measures
Effect of reldesemtiv versus placebo on combined functional and survival outcomes in ALS
Effect of reldesemtiv versus placebo on handgrip strength
Effect of reldesemtiv versus placebo on quality of life
+1 more

Side effects data

From 2019 Phase 2 trial • 458 Patients • NCT03160898
14%
Headache
13%
Fatigue
11%
Diarrhoea
9%
Nausea
7%
Skin abrasion
7%
Contusion
7%
Dizziness
7%
Arthralgia
6%
Cystatin C increased
6%
Constipation
6%
Upper respiratory tract infection
5%
Glomerular filtration rate decreased
5%
Post-traumatic pain
5%
Muscle spasms
5%
Viral upper respiratory tract infection
3%
Urinary tract infection
3%
Decreased appetite
2%
Dry mouth
2%
Aspartate aminotransferase increased
2%
Dysphagia
2%
Alanine aminotransferase increased
1%
Appendicitis
1%
Oesophagitis
1%
Muscle contractions involuntary
1%
Dyspnoea
1%
Joint dislocation
1%
Weight decreased
1%
Pain
1%
Pain in extremity
1%
Dehydration
1%
Pruritus
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

COURAGE-ALS Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 300 mg reldesemtiv twice daily for a 600 mg total daily dose, from Week 24 until Week 48Experimental Treatment1 Intervention
Patients in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48 for patients who were not down titrated during the 24 weeks of blinded dosing.
Group II: 300 mg reldesemtiv twice daily for a 600 mg total daily dose, from Day 1 until Week 24Experimental Treatment1 Intervention
Patients 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 III: 150 mg reldesemtiv twice daily for a 300 mg total daily dose, from Week 24 until Week 48Experimental Treatment1 Intervention
Patients in this arm take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48 for patients who were down titrated for any reason during the 24 weeks of blinded dosing.
Group IV: Placebo twice daily, from Day 1 until Week 24Placebo Group1 Intervention
Patients 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
40 Previous Clinical Trials
14,822 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
2,408 Patients Enrolled for Amyotrophic Lateral Sclerosis
Cytokinetics, MDStudy DirectorCytokinetics
5 Previous Clinical Trials
1,094 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the unique qualities of this clinical trial?

"Reldesemtiv has been under clinical testing since 2021. In the first trial, 555 patients were observed. After successfully completing Phase 3 drug approval in 2021, there is currently one active study being conducted by Cytokinetics."

Answered by AI

Do patients over the age of 80 still qualify for this research opportunity?

"The age range for patients that are applicable for this trial is between 18 and 80 years old. In contrast, there are 45 other studies involving patients that are below the age of majority and 408 research trials studying senior citizens."

Answered by AI

What other scientific examinations have included Reldesemtiv?

"Reldesemtiv is being studied in 1 ongoing clinical trial, with 83 research sites worldwide. Of these studies, 1 is currently in Phase 3."

Answered by AI

Are there restrictions for who can take part in this experiment?

"This study is looking for 555 participants that match the following profile: currently have amyotrophic lateral sclerosis, between 18-80 years old, an ALSFRS-R total score ≤ 44, males or females, must be either on riluzole for ≥ 30 days prior to screening or not taken it for at least 30 days prior to screening, completed at least 2 cycles of edaravone at time of screening or not received it for at least 30 days prior to screening, first symptom of ALS ≤ 24 months prior to screening , able to swallow whole tablets."

Answered by AI

Could you provide a breakdown of how many different places this trial is taking place?

"There are a total of 48 patients enrolled in this study, with locations including the Atrium Health Neuroscience Institute - Charlotte in Charlotte, Oregon Health and Science University in Portland, and University of Alberta in Edmonton."

Answered by AI

What is the FDA's verdict on Reldesemtiv?

"The drug Reldesemtiv has received a Phase 3 classification, meaning that there is both efficacy data and multiple rounds of safety data available. Our team rates the safety as a 3 on our 1 to 3 scale."

Answered by AI

Who else is applying?

What state do they live in?
New York
Illinois
How old are they?
18 - 65
65+
What site did they apply to?
Duchossois Center for Advanced Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)
2021. "A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04944784.
~133 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top