drugset / Trial / NCT05162768
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
SPIMD-301 is a 48-week, randomized, double-blind, parallel-group, placebo-controlled trial to assess efficacy and safety of single daily subcutaneous (SC) administration of elamipretide as a treatment for subjects with primary mitochondrial myopathy associated with nuclear DNA mutations (nPMD).
Timeline
- Start
- 2022-04-29
- Primary completion
- 2024-09-30
- Completion
- 2024-12-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elamipretide | Peptide | 60 mg | Subcutaneous |