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Project

SPIMD-301

Center:
Fiscal Year:
2024
Contact Information:
Project Description:
Title: SPIMD-301: A phase 3 randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of daily subcutaneous injections of Elamipretide in subjects with primary mitochondrial disease resulting from pathogenic nuclear DNA mutations (nPMD) Role: Collaborator (Site PI-Russo) Funding: Stealth Biotherapeutics 2022-present Summary: This is a prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Elamipretide in subjects with primary nuclear mitochondrial myopathy.
Keyword(s):
Core Function(s):
Performing Research or Evaluation, Continuing Education/Community Training
Area of Emphasis
Other
Target Audience:
Children/Adolescents with Disabilities/SHCN
Unserved or Under-served Populations:
Other
Primary Target Audience Geographic Descriptor:
National
Funding Source:
COVID-19 Related Data:
N/A