Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Mitochondrial Disease

In brief

This randomized, double-blind, placebo-controlled, crossover study screened 32 subjects with primary mitochondrial myopathy (PMM) to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of subcutaneous elamipretide in this patient population.

Key facts

Study ID

NCT02805790

Run by

Stealth BioTherapeutics Inc.

People needed

30

Starts

2016-08-22

Expected to finish

2017-03-23

Last updated by the study team

2020-07-17

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject completed participation in the SPIMM-201 study without a significant protocol deviation that would suggest the subject may not be able to complete all study requirements in the opinion of the Sponsor
• Subject must reside in North America for the duration of the study
• Subject has not received study drug in the SPIMM-201 study within 3 weeks prior to Screening
• Women of childbearing potential must agree to use 1 of the methods of birth control specified in the protocol from the date they sign the informed consent form (ICF) until two months after the last dose of study drug
• Subject has been on stable (unchanged and constant) medications (including over-the counter treatments, vitamins, or supplements) for at least 1 month prior to the Baseline Visit

You may not qualify if…

• Subject has any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements (i.e. unstable angina or recent myocardial infarction)
• Subject has received any investigational compound and/or has participated in another interventional clinical study within 30 days prior to the Baseline Visit or is concurrently enrolled in any non-interventional research of any type judged to be scientifically or medically incompatible with the study as deemed by the Investigator in consultation with the Sponsor
• Subject experienced an adverse reaction to study drug in the SPIMM-201 study that contraindicates further treatment with elamipretide in the opinion of the Investigator and/or Sponsor
• Female subjects who are pregnant, planning to become pregnant, or lactating
• Subject has undergone an in-patient hospitalization within the 1 month prior to the Screening Visit or is likely to need in-patient hospitalization or a surgical procedure during the course of the study
• Subject has a creatinine clearance ≤30 mL/min as calculated by the Cockcroft Gault equation
• Subject has a corrected QT interval (QTc) elongation defined as a QTc >450 msec in male subjects and >480msec in female subjects. Note: At the initial electrocardiogram (ECG), if QTc exceeds these parameters, the ECG may be repeated 2 more times, and the average of the 3 QTc values used to determine the subjects eligibility
• Subject has uncontrolled hypertension in the judgment of the Investigator (e.g. elevated above >160 mmHg systolic or >100 mmHg diastolic despite appropriate treatment on two consecutive readings)
• Subject has a history of clinically significant hypersensitivity or allergy to any of the excipients contained in the study drug
• Subject has a history of active alcoholism or drug addiction during the year before the Screening Visit

Where it is running

• University of California — San Diego, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Children's Hospital of Pittsburg of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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