← Back to Search

Mitochondrial Peptide

Elamipretide for Mitochondrial Myopathy (NuPower Trial)

Phase 3
Waitlist Available
Research Sponsored by Stealth BioTherapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with nPMD with a predominant clinical manifestation of myopathy, which must include progressive external ophthalmoplegia (PEO) and exercise intolerance and/or skeletal muscle weakness, with genetic confirmation of either nuclear DNA mutation of the mitochondrial replisome (replisome-related mutations) or other pathogenic mutations specific to nuclear DNA
MPV17 or
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 12, 24, 36, 48, 52 (end of trial visit)
Awards & highlights

NuPower Trial Summary

This trial is testing a potential treatment for a certain kind of mitochondrial myopathy, a degenerative disease. It is a long trial, lasting 48 weeks, and is double-blind (neither patient nor doctor knows who is receiving the real treatment).

Who is the study for?
Adults aged 18-70 with primary mitochondrial myopathy from nuclear DNA mutations, including progressive external ophthalmoplegia and muscle weakness. Participants must agree to trial requirements and contraception use. Excluded are those with recent major medical events, severe neurological issues, substance abuse history, certain infections or transplants, participation in other trials within 30 days, significant kidney impairment, inability to perform specific functional tests, pregnancy/breastfeeding status or certain walking limitations.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of Elamipretide given daily through a subcutaneous injection compared to a placebo over a period of 48 weeks. The focus is on individuals with mitochondrial myopathy due to nuclear DNA mutations.See study design
What are the potential side effects?
While not specified here, potential side effects may include reactions at the injection site such as redness or pain; general symptoms like fatigue or headache; and possibly more serious conditions related to organs affected by mitochondrial disease.

NuPower Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have nPMD with symptoms like eye movement issues and muscle weakness, confirmed by genetic tests.
Select...
My condition involves the MPV17 gene.
Select...
I am between 18 and 70 years old.
Select...
I meet the specific study's eligibility criteria.

NuPower Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 12, 24, 36, 48, 52 (end of trial visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 12, 24, 36, 48, 52 (end of trial visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Six-minute walk test (6MWT)
Secondary outcome measures
5 times sit-to-stand test (5XSST)
Patient Global Impression of Severity (PGI-S) Scale
Triple Timed up-and-go test (3TUG)

Side effects data

From 2016 Phase 2 trial • 41 Patients • NCT02245620
5%
Herpes zoster
5%
Palpitations
5%
Sinus congestion
5%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Elamipretide
Placebo

NuPower Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ElamipretideExperimental Treatment1 Intervention
0.75 mL of 80mg/mL solution of elamipretide for a single daily SC dose of 60mg elamipretide
Group II: PlaceboPlacebo Group1 Intervention
0.75 mL of 80mg/mL solution of matching placebo for a single daily SC dose of 60mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elamipretide
2016
Completed Phase 3
~130

Find a Location

Who is running the clinical trial?

Stealth BioTherapeutics Inc.Lead Sponsor
27 Previous Clinical Trials
1,786 Total Patients Enrolled

Media Library

Elamipretide (Mitochondrial Peptide) Clinical Trial Eligibility Overview. Trial Name: NCT05162768 — Phase 3
Mitochondrial Disease Research Study Groups: Elamipretide, Placebo
Mitochondrial Disease Clinical Trial 2023: Elamipretide Highlights & Side Effects. Trial Name: NCT05162768 — Phase 3
Elamipretide (Mitochondrial Peptide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05162768 — Phase 3
Mitochondrial Disease Patient Testimony for trial: Trial Name: NCT05162768 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators still recruiting individuals for this research project?

"The trial, as indicated by information on clinicaltrials.gov, is still recruiting patients. The posting went up on 4/29/2022 and the most recent edit was on 11/8/2022."

Answered by AI

Are people who are over 25 years old allowed to participate in this research?

"The age requirement to participate in this specific trial is between 18-70. However, if an applicant does not meet this criterion, there are 19 other clinical trials that they might be eligible for. For seniors aged 65 and over, there are 43 different trials listed."

Answered by AI

Are there a lot of research facilities conducting this experiment within the state's borders?

"The trial's primary locations are Massachusetts General Hospital in Boston, MA, Austin Neuromuscular Center Neurology in Austin, TX, and Medical College of Wisconsin Froedtert Dept. of Neurology in Milwaukee, WI. Other sites include 9 other locations."

Answered by AI

Can you give some background on Elamipretide's clinical trial history?

"Elamipretide was first studied in 2022 at Children's Hospital of Philadelphia - Neurology. Out of the 18,286 completed studies, there are only 2 active trials. These remaining studies are both located in Boston, Massachusetts."

Answered by AI

When will Elamipretide be cleared for public use?

"Elamipretide is estimated to be a 3 on the Power team's safety scale. This is because it is in Phase 3 trials, meaning that not only does some data support its efficacy, but multiple rounds of data confirm its safety."

Answered by AI

To your knowledge, is this the first time this kind of experiment has been conducted?

"In total, there have been 18286 Elamipretide trials completed in the last year. The first study was conducted in 2022 and involved 18 patients. Currently, there are 2 active studies being performed across 14 cities and 10 countries."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
UT Health,Center for the Treatment of Pediatric Neurodegenerative Disease
Columbia University Medical Center College of Physician and Surgeon
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have DES mutation causing mtDNA Multiple Large Scale Depletion Syndrome.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
2022. "Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05162768.
All > Mitochondrial Disease > Muscular Dystrophy
~15 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top