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Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)

NCT01709149 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 711

Last updated 2020-03-31

Study results available
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Summary

The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

Conditions

Interventions

DRUG

CK-2017357

CK-2017357 125 mg tablets twice daily

OTHER

Placebo tablets

Tablets

DRUG

Riluzole

Tablets

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Jinsy Andrews, MD · Cytokinetics, Inc.

  • Jeremy Shefner, MD, PhD · State University of New York - Upstate Medical University

  • Jeremy Shefner, MD, PhD · State University of New York - Upstate Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Ireland
  • Netherlands
  • Spain
  • 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 NCT01709149 on ClinicalTrials.gov