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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

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 ~ 24 weeks

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

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 ALS

Secondary study objectives

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

Nausea

Dizziness

Contusion

Skin abrasion

Arthralgia

Upper respiratory tract infection

Cystatin C increased

Constipation

Muscle spasms

Viral upper respiratory tract infection

Post-traumatic pain

Glomerular filtration rate decreased

Urinary tract infection

Decreased appetite

Alanine aminotransferase increased

Aspartate aminotransferase increased

Dysphagia

Dry mouth

Joint dislocation

Oesophagitis

Appendicitis

Muscle contractions involuntary

Dyspnoea

Dehydration

Weight decreased

Pruritus

Pain

Pain in extremity

100%

80%

60%

40%

20%

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: 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

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