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A Study of CK-2127107 in Patients With Spinal Muscular Atrophy

NCT02644668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-08-31

Study results available
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Summary

This study will evaluate the pharmacodynamic (PD) effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on measures of skeletal muscle function or fatigability in patients with Type II, III, or IV spinal muscular atrophy (SMA).

Conditions

Interventions

DRUG

Placebo

Granules for oral suspension (placebo)

DRUG

Reldesemtiv 150 mg

Granules for oral suspension, 18.7% reldesemtiv

DRUG

Reldesemtiv 450 mg

Granules for oral suspension, 56.0% reldesemtiv

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    collaborator INDUSTRY

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • MD, Cytokinetics · Cytokinetics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-14
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT02644668 on ClinicalTrials.gov