A Study of CK-2127107 in Patients With Spinal Muscular Atrophy
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).
Timeline
- Start
- 2016-01-14
- Primary completion
- 2018-05-31
- Completion
- 2018-05-31
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Placebo vs Reldesemtiv 150 mg Twice Daily; p = 0.0378; Least squares mean difference 11.69 (95% CI 0.68 to 22.70) reads as mixed primary results NCT02644668 ↗
registry analysis (superiority test); Placebo vs Reldesemtiv 150 mg Twice Daily; p = 0.9086; Least squares mean difference -0.01 (95% CI -0.13 to 0.11) reads as mixed primary results NCT02644668 ↗
release “This hypothesis-generating study met its primary objective to determine potential pharmacodynamic effects of reldesemtiv after multiple oral doses in patients with SMA” reads as met primary endpoint cytokinetics.com ↗
release “study of reldesemtiv in patients with SMA showed a statistically significant exposure-response relationship in changes from baseline in Six Minute Walk Distance (6MWD)” reads as met primary endpoint cytokinetics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Reldesemtiv | Small molecule | 150 mg | Oral |
| Subject | Reldesemtiv | Small molecule | 450 mg | Oral |