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Skeletal Muscle Activator

Reldesemtiv for Amyotrophic Lateral Sclerosis (COURAGE OLE 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 48
Awards & highlights

COURAGE OLE Trial Summary

This trial will test the safety of a drug for people with ALS who have completed a previous trial.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

COURAGE OLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long-term safety and tolerability of reldesemtiv in patients with ALS
Secondary outcome measures
Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031

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 OLE Trial Design

1Treatment groups
Experimental Treatment
Group I: Reldesemtiv 300 mg twice dailyExperimental Treatment1 Intervention
Patients in this arm take 1 reldesemtiv 300 mg oral tablet twice a day for a 600 mg total daily dose (TDD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reldesemtiv
Not yet FDA approved

Find a Location

Who is running the clinical trial?

CytokineticsLead Sponsor
40 Previous Clinical Trials
15,236 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
2,822 Patients Enrolled for Amyotrophic Lateral Sclerosis
Cytokinetics MDStudy ChairScientific Leadership at Cytokinetics
2 Previous Clinical Trials
702 Total Patients Enrolled

Frequently Asked Questions

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

Are patients able to sign up for this experiment at this time?

"Yes, this clinical trial is actively recruiting patients, according to the latest update on clinicaltrials.gov from October 23rd, 2022. The study was originally posted on the website on July 25th, 2020."

Answered by AI

Has Reldesemtiv been accepted by the FDA?

"Reldesemtiv has received a score of 3 for safety. This is due to the fact that Reldesemtiv is a Phase 3 trial, so while there is some data supporting efficacy, there is also multiple rounds of data supporting safety."

Answered by AI

How many people are included in this research project at most?

"That is correct. The clinical trial in question, as seen on clinicaltrials.gov, is actively recruiting patients. The listing was first posted on 7/25/2022 and was updated as recently as 10/23/2022. They are looking for 400 participants total, to be spread out across 13 locations."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
McMaster University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
2022. "A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05442775.
~27 spots leftby Apr 2025
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