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NCT01709149 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Cytokinetics.

Completed
Registry status
Phase 2
Development phase
711
Enrollment target
20
Study locations

NCT01709149: Completed Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Cytokinetics.

NCT01709149 is a Phase 2 study of Amyotrophic Lateral Sclerosis that has completed, run by Cytokinetics. The registered enrollment target is 711 participants, below the 891-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01709149, a Phase 2 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by Cytokinetics.

COMPLETED
Registry status
Phase 2
Development phase
711 participants
Enrollment target
20
Study locations

Study 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).

Primary Outcome

The ALSFRS-R is used to measure the progression and severity of disease; it consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48, with higher scores reflecting more normal function and lower scores reflecting m

Interventions

  • DRUG Riluzole
  • DRUG CK-2017357
  • OTHER Placebo tablets

Study Locations (20)

California

  • University of California, San Diego - La Jolla
  • UC Irvine ALS & Neuromuscular Center - Orange
  • Coordinated Clinical Research - San Diego
  • California Pacific Medical Center Forbes Norris MDA/ALS Research Center - San Francisco

Michigan

  • University of Michigan - Ann Arbor
  • Henry Ford Hospital - Detroit
  • St Mary's Healthcare - Grand Rapids

Georgia

  • Emory University, School of Medicine - Atlanta
  • Georgia Health Sciences University - Augusta

Massachusetts

  • Massachusetts General Hospital - Boston
  • University of Massachusetts Medical School - Worcester

Arizona

  • Barrow Neurology - Phoenix

Connecticut

  • Hospital for Special Care - New Britain

District of Columbia

  • The George Washington University - Washington D.C.

Florida

  • Mayo Clinic Florida Department of Neurology - Jacksonville

Trial Details

FieldValue
Enrollment Target 711 participants
Start Date 2012-10
Est. Completion 2014-03
Phase Phase 2
Cytokinetics

31 total trials

What the finished NCT01709149 record still lists

NCT01709149 is an interventional study that assigns participants to a tested intervention. The registered 711 participants enrollment target is mid-sized for trials with a published cap, below the 891-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (20% lower).

The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Riluzole is the first listed.

NCT01709149 names 20 study sites across 13 states, led by California, Michigan, Georgia.

Frequently Asked Questions

What is clinical trial NCT01709149 about?

NCT01709149 is a clinical study titled "Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)". 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).

What is the current status of trial NCT01709149?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 711 participants. The study started on 2012-10. Estimated completion is 2014-03.

What conditions does trial NCT01709149 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.

What interventions are being tested in trial NCT01709149?

The interventions under investigation include: Riluzole (DRUG), CK-2017357 (DRUG), Placebo tablets (OTHER).

Who is sponsoring clinical trial NCT01709149?

This trial is sponsored by Cytokinetics, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01709149 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Amyotrophic Lateral Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01709149's enrollment target sits among peer trials

711 14th of 102 higher than 89 of 102 other Amyotrophic Lateral Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01709149, the US trial registry maintained by the National Library of Medicine. NCT01709149 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.