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NCT01486849 · ClinicalTrials.gov registry record · Phase 2
Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by Cytokinetics.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT01486849 is a Phase 2 study that has completed, run by Cytokinetics. The registered enrollment target is 27 participants.
The verdict
NCT01486849, a Phase 2 study, has completed, sponsored by Cytokinetics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Placebo
- DRUG Riluzole 50 MG
- DRUG CK-2017357
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01486849
The ClinicalTrials.gov registry entry for NCT01486849 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cytokinetics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01486849 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01486849 about?
NCT01486849 is a clinical study titled "Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)". 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 dai...
What is the current status of trial NCT01486849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2011-11. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01486849?
The interventions under investigation include: Placebo (DRUG), Riluzole 50 MG (DRUG), CK-2017357 (DRUG).
Who is sponsoring clinical trial NCT01486849?
This trial is sponsored by Cytokinetics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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