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Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

NCT02367014 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-12-27

Study results available
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Summary

Phase 1/2, multi-center, randomized, double-blind, multiple ascending dose, placebo-controlled study that enrolled 36 subjects with mitochondrial myopathy associated with genetically confirmed mitochondrial disease to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient population.

Conditions

  • Mitochondrial Myopathy

Interventions

DRUG

elamipretide (low dose)

elamipretide (0.01 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days

DRUG

elamipretide (intermediate dose)

elamipretide (0.10 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days

DRUG

elamipretide (high dose)

elamipretide (0.25 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days

DRUG

Placebo

placebo (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days

Sponsors & Collaborators

  • Stealth BioTherapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367014 on ClinicalTrials.gov