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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.
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 711 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
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.
Learn More About Clinical Trials
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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