A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT03160898 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2020-09-11

Study results available
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Summary

The purpose of this study was to assess the effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS.

Conditions

Interventions

DRUG

Reldesemtiv

Oral tablet

DRUG

Placebo

Oral tablet

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY
  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • MD Cytokinetics · 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
2017-07-24
Primary Completion
2019-03-07
Completion
2019-03-07
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Ireland
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

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 NCT03160898 on ClinicalTrials.gov