Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Public ClinicalTrials.gov record NCT01486849. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose Titration Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase II, double-blind, randomized, placebo-controlled ascending dose titration study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple ascending doses of CK-2017357 to an individual patient maximum tolerated dose (MTD), using a within-patient twice daily (BID) dose-titration regimen in ALS patients on 50 mg riluzole once daily (QD).
Study identification
- NCT ID
- NCT01486849
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2011
- Primary completion
- Feb 29, 2012
- Completion
- Feb 29, 2012
- Last update posted
- May 2, 2019
2011 – 2012
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at San Francisco, Fresno Campus, Central California Neurological Institute | Fresno | California | 93701 | — |
| Coordinated Clinical Research | La Jolla | California | 92037 | — |
| University of California at Irvine, ALS and Neuromuscular Center | Orange | California | 92868 | — |
| Hospital for Special Care | New Britain | Connecticut | 06053 | — |
| Massachusetts General Hospital, Neurology Clinical Trials Unit | Charlestown | Massachusetts | 02129 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Cornell Faculty, Hospital for Special Surgery | New York | New York | 10021 | — |
| Duke University School of Medicine, Division of Neurology | Durham | North Carolina | 27710 | — |
| Ohio State University, Department of Neurology | Columbus | Ohio | 43210 | — |
| Providence ALS Center | Portland | Oregon | 97213 | — |
| University of Texas Health Science Center, Department of Neurology | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01486849, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 2, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01486849 live on ClinicalTrials.gov.