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RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
NCT02255422 · View on ClinicalTrials.gov ↗
Study Summary
Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a wide range of biochemical and genetic mitochondrial defects and variable modes of inheritance. Currently there are no effective treatments for this disease. Despite the heterogeneous myopathy phenotypes, a unifying feature of mitochondrial myopathies is that the pathogenic mtDNA mutations and/or nuclear mutations of the electron transport chain invariably lead to dysfunctional mitochondrial respiration. This reduction in mitochondrial respiration leads to a reduced ability to produce cellular adenosine triphosphate (ATP), often resulting in muscle weakness, exercise intolerance, and fatigue in patients with mitochondrial myopathies. RTA 408 is a potent activator of Nrf2 and inhibitor of NF κB (nuclear factor kappa-light-chain-enhancer of activated B cells), and thus induces an antioxidant and anti-inflammatory phenotype. Several lines of evidence suggest that Nrf2 activation can increase mitochondrial respiration and biogenesis. Collectively, available data suggest that the ability of RTA 408 to activate Nrf2 and induce its target genes could potentially improve muscle function, oxidative phosphorylation, antioxidant capacity, and mitochondrial biogenesis in patients with mitochondrial myopathies. This study will be a randomized, placebo-controlled, double-blind, dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in patients with mitochondrial myopathies.
Conditions Studied
Interventions
- DRUG Placebo capsules
- DRUG Omaveloxolone capsules, 2.5 mg
- DRUG omaveloxolone capsules, 5 mg
- DRUG omaveloxolone capsules, 10 mg
- DRUG omaveloxolone capsules, 20 mg
Study Locations (9)
Texas
- Insitute for Exercise & Environmental Medicine — Dallas
- Baylor College of Medicine — Houston
- University of Texas Medical School at Houston — Houston
Pennsylvania
- The Children's Hospital of Philadelphia — Philadelphia
- University of Pittsburgh — Pittsburgh
California
- UCLA — Los Angeles
Massachusetts
- Mass General Hospital — Boston
Ohio
- Akron Children's Hospital — Akron
Other
- Neuromuscular Clinic, Rigshospitalet, University of Copenhagen — Copenhagen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2015-05-05 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02255422
The ClinicalTrials.gov registry entry for NCT02255422 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with MItochondrial Myopathies appearing as the primary indexed condition, and to 5 interventions — of which Placebo capsules is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02255422 reports 9 study locations spanning 6 distinct geographic areas — top geographies include Texas, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02255422 about?
NCT02255422 is a clinical study titled "RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR". Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a wide range of biochemical and genetic mitochondrial defects and variable modes of inheritance. Currently there are no effective treatments for this disease. Despite the heterogeneous myopathy phenotypes, a un...
What is the current status of trial NCT02255422?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2015-05-05. Estimated completion is 2017-11-30.
What conditions does trial NCT02255422 study?
This clinical trial studies the following conditions: MItochondrial Myopathies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02255422?
The interventions under investigation include: Placebo capsules (DRUG), Omaveloxolone capsules, 2.5 mg (DRUG), omaveloxolone capsules, 5 mg (DRUG), omaveloxolone capsules, 10 mg (DRUG), omaveloxolone capsules, 20 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02255422?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02255422 being conducted?
This trial has 9 study locations across California, Massachusetts, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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