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A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT04944784 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 489

Last updated 2024-12-05

Study results available
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Summary

The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

Conditions

Interventions

DRUG

Reldesemtiv

Reldesemtiv Oral Tablet

DRUG

Placebo

Placebo Oral Tablet

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Cytokinetics, MD · Cytokinetics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2023-07-18
Completion
2023-07-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944784 on ClinicalTrials.gov