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NCT02255422 · ClinicalTrials.gov registry record · Phase 2
RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
A Phase 2 study of MItochondrial Myopathies, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 9
- Study locations
NCT02255422: Completed Phase 2 study of MItochondrial Myopathies, sponsored by Biogen.
NCT02255422 is a Phase 2 study of MItochondrial Myopathies that has completed, run by Biogen. The registered enrollment target is 53 participants, roughly in line with the 57-participant average among 4 other MItochondrial Myopathies trials with a reported enrollment target. The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02255422, a Phase 2 study of MItochondrial Myopathies, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Cycle ergometry using a stationary recumbent bike was used to conduct maximal exercise testing. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion). Change of peak workload during exercise testing was measured at baseline, Week 4, and Week 12. Change from baseline at Week 12 reported.
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 |
What the finished NCT02255422 record still lists
NCT02255422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, roughly in line with the 57-participant average among 4 other MItochondrial Myopathies trials with a reported enrollment target.
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.
NCT02255422 lists 9 locations in 6 states (Texas, Pennsylvania, California).
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.
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).
Who is sponsoring clinical trial NCT02255422?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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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