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Omaveloxolone capsules
RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
Ensayo de BIOGEN INC. en Miopatias mitocondriales.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 53
- Centros
- 9
- Fin del objetivo primario
- nov 2017
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en may 2015.
Qué mide
Cambio en la carga de trabajo maxima (en vatios/kg) durante la prueba de esfuerzo (12 semanas)
Cómo lo describe el promotor
En el documentoEn inglés, del registroMitochondrial 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.
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Ficha completa en ClinicalTrials.gov (NCT02255422), actualizada en may 2025.