Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02255422 | RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR | PHASE2 | COMPLETED | 53 | — | — | May 5, 2015 | Nov 30, 2017 | Jun 5, 2025 | 9 | United States, Denmark |
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.
| Arm | Type | Description |
|---|---|---|
| omaveloxolone Capsules 2.5 mg and 5 mg | EXPERIMENTAL | omaveloxolone (RTA 408) Capsules, 2.5 mg taken orally once daily for 2 weeks, then 5 mg taken orally once daily for 10 weeks |
| omaveloxolone Capsules 10 mg | EXPERIMENTAL | omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 12 weeks |
| Placebo Capsules | PLACEBO_COMPARATOR | Placebo capsules taken orally once daily for 12 weeks |
| omaveloxolone Capsules 20 mg | EXPERIMENTAL | omaveloxolone (RTA 408) Capsules, 20 mg taken orally once daily for 12 weeks. |
| omaveloxolone Capsules 40 mg | EXPERIMENTAL | omaveloxolone (RTA 408) Capsules, 40 mg taken orally once daily for 12 weeks. |
| omaveloxolone Capsules 80 mg | EXPERIMENTAL | omaveloxolone (RTA 408) Capsules, 80 mg taken orally once daily for 12 weeks. |
| omaveloxolone Capsules 160 mg | EXPERIMENTAL | omaveloxolone (RTA 408) Capsules, 160 mg taken orally once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Omaveloxolone capsules, 2.5 mg | DRUG | - |
| omaveloxolone capsules, 5 mg | DRUG | - |
| omaveloxolone capsules, 10 mg | DRUG | - |
| Placebo capsules | DRUG | - |
| omaveloxolone capsules, 20 mg | DRUG | - |
| omaveloxolone capsules, 40 mg | DRUG | - |
| omaveloxolone capsules, 80 mg | DRUG | - |
| omaveloxolone capsules, 160 mg | DRUG | - |
Inclusion Criteria: 1. Have mitochondrial myopathy as evidenced by the following 2 criteria (must meet both): 1. Have a history of exercise intolerance with or without weakness and/or progressive exercise intolerance (in which modest exercise typically provokes heaviness, weakness, aching of ac...