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Showing 1–7 of 7 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Conditions
MItochondrial Myopathies
Interventions
Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg, Placebo capsules, omaveloxolone capsules, 20 mg, omaveloxolone capsules, 40 mg, omaveloxolone capsules, 80 mg, omaveloxolone capsules, 160 mg
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 75 Years
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
8
States / cities
Los Angeles, California • Boston, Massachusetts • Akron, Ohio + 4 more
Completed Phase 1Phase 2 Interventional Results available

RTA 408 Capsules in Patients With Melanoma - REVEAL

NCT02259231
Conditions
Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) Melanoma
Interventions
Omaveloxolone Capsules (2.5 mg/capsule), Ipilimumab (3 mg/kg), Nivolumab (240 mg), Omaveloxolone Capsules (10 mg/capsule), Omaveloxolone Capsules (50 mg/capsule)
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
10
States / cities
Mobile, Alabama • Fayetteville, Arkansas • Aurora, Colorado + 7 more
Conditions
Friedreich Ataxia
Interventions
Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg, Placebo, Omaveloxolone Capsules, 20 mg, Omaveloxolone Capsules, 40 mg, Omaveloxolone Capsules, 80 mg, Omaveloxolone Capsules, 160 mg, Omaveloxolone Capsules, 300 mg, Omaveloxolone Capsules, 150 mg
Drug
Lead sponsor
Biogen
Industry
Eligibility
16 Years to 40 Years
Enrollment
172 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2025
U.S. locations
7
States / cities
Los Angeles, California • Gainesville, Florida • Tampa, Florida + 4 more
Completed Phase 1 Interventional Accepts healthy volunteers

A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

NCT04008186
Conditions
Healthy Adult Subjects
Interventions
Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG, MetFORMIN 500 Mg Oral Tablet, Rosuvastatin, Digoxin tablet, Gemfibrozil Tablets, Itraconazole capsule, Verapamil Pill
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years
Enrollment
61 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Dallas, Texas
Conditions
Hepatic Impairment
Interventions
Omaveloxolone 50 mg capsules
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 70 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2020
U.S. locations
3
States / cities
Tustin, California • Miami, Florida • Orlando, Florida
Completed Phase 1 Interventional Accepts healthy volunteers

A Human AME Study for Omaveloxolone

NCT03931590
Conditions
Healthy Male Subjects
Interventions
[14C]-Omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Madison, Wisconsin
Conditions
Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma
Interventions
omaveloxolone
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years to 75 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Tampa, Florida