At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Reldesemtiv 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study of CK-2127107 in Two Ascending Dose Cohorts of Patients With Spinal Muscular Atrophy
In Brief
A Phase 2 clinical trial evaluating Placebo, Reldesemtiv 150 mg, and 1 other intervention for Spinal Muscular Atrophy. Completed, enrolled 70 participants across 19 sites in 2 countries.
Detailed Summary
This study will evaluate the pharmacodynamic (PD) effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on measures of skeletal muscle function or fatigability in patients with Type II, III, or IV spinal muscular atrophy (SMA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Muscular Atrophy
CountriesCanada, United States
CollaboratorsAstellas Pharma Global Development, Inc.
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartJan 2016
Primary CompletionMay 2018
TodayJul 2026
First PostedJan 1, 2016
Enrollment StartJan 14, 2016
Primary CompletionMay 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.5 years ago
Interventions
Placebodrug
Granules for oral suspension (placebo)
Reldesemtiv 150 mgdrug
Granules for oral suspension, 18.7% reldesemtiv
Reldesemtiv 450 mgdrug
Granules for oral suspension, 56.0% reldesemtiv