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ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:31 AM EDT

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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Idebenone Clear all
Completed Phase 3 Interventional Results available

Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)

NCT01027884
View directory record Official record
Conditions
Muscular Dystrophy, Duchenne, Ambulatory Care
Interventions
Placebo, Idebenone
Drug
Lead sponsor
Santhera Pharmaceuticals
Industry
Eligibility
10 Years to 18 Years · Male only
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2014
U.S. locations
9
States / cities
Sacramento, California • Aurora, Colorado • Gainesville, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Oct 19, 2015 · Synced Oct 21, 2026, 6:31 AM EDT
No Longer Available No phase listed Expanded access

Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)

NCT03433807
View directory record Official record
Conditions
Duchenne Muscular Dystrophy
Interventions
Idebenone
Drug
Lead sponsor
Santhera Pharmaceuticals
Industry
Eligibility
8 Years and older
U.S. locations
12
States / cities
Phoenix, Arizona • New Haven, Connecticut • Chicago, Illinois + 9 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2023 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 3 Interventional Results available

Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia

NCT00537680
View directory record Official record
Conditions
Friedreich's Ataxia
Interventions
Idebenone, Placebo
Drug
Lead sponsor
Santhera Pharmaceuticals
Industry
Eligibility
8 Years to 17 Years
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
2
States / cities
Los Angeles, California • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jul 11, 2023 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis

NCT04669158
View directory record Official record
Conditions
Non Alcoholic Steatohepatitis, Fibrosis
Interventions
Idebenone, Placebo
Drug
Lead sponsor
Stanford University
Other
Eligibility
18 Years and older
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
2
States / cities
Redwood City, California • Stanford, California
Source: ClinicalTrials.gov public record
Updated Apr 24, 2026 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 3 Interventional Results available

Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

NCT00697073
View directory record Official record
Conditions
Friedreich's Ataxia
Interventions
Idebenone
Drug
Lead sponsor
Santhera Pharmaceuticals
Industry
Eligibility
8 Years to 18 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
2
States / cities
Los Angeles, California • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jul 11, 2023 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Idebenone for Primary Progressive Multiple Sclerosis

NCT01854359
View directory record Official record
Conditions
Multiple Sclerosis, Primary Progressive Multiple Sclerosis
Interventions
Idebenone
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated May 19, 2021 · Synced Oct 21, 2026, 6:31 AM EDT
Terminated Phase 3 Interventional

Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)

NCT03603288
View directory record Official record
Conditions
Duchenne Muscular Dystrophy
Interventions
idebenone 150 mg film-coated tablets
Drug
Lead sponsor
Santhera Pharmaceuticals
Industry
Eligibility
11 Years and older · Male only
Enrollment
161 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
13
States / cities
Birmingham, Alabama • Tucson, Arizona • Los Angeles, California + 10 more
Source: ClinicalTrials.gov public record
Updated Dec 3, 2021 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 1 Interventional

Phase 1 Trial of Idebenone to Treat Patients With Friedreich's Ataxia

NCT00078481
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Idebenone
Drug
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eligibility
Not listed
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2006
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 4, 2008 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)

NCT00950248
View directory record Official record
Conditions
Primary Progressive Multiple Sclerosis
Interventions
Idebenone, placebo
Drug · Other
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 19, 2019 · Synced Oct 21, 2026, 6:31 AM EDT
Terminated Phase 3 Interventional

A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids

NCT02814019
View directory record Official record
Conditions
Duchenne Muscular Dystrophy (DMD)
Interventions
Idebenone 150 mg film-coated tablets, placebo
Drug
Lead sponsor
Santhera Pharmaceuticals
Industry
Eligibility
10 Years and older · Male only
Enrollment
255 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
20
States / cities
Birmingham, Alabama • Phoenix, Arizona • Tucson, Arizona + 16 more
Source: ClinicalTrials.gov public record
Updated Dec 3, 2021 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 2 Interventional

Idebenone to Treat Friedreich's Ataxia

NCT00229632
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Idebenone
Drug
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eligibility
9 Years to 17 Years
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 18, 2019 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 4 Interventional Results available

Study to Assess the Efficacy and Safety of Raxone in LHON Patients

NCT02774005
View directory record Official record
Conditions
Leber's Hereditary Optic Neuropathy (LHON)
Interventions
Idebenone
Drug
Lead sponsor
Santhera Pharmaceuticals
Industry
Eligibility
12 Years and older
Enrollment
199 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2021
U.S. locations
9
States / cities
Phoenix, Arizona • Palo Alto, California • Stanford, California + 6 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2023 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 2 Interventional

ROAR-DIGAP: A Widely Inclusive, Largely Virtual Pilot Trial Utilizing DIGAP (Deep Integrated Genomics Analysis Platform) To Personalize Treatments

NCT06429059
View directory record Official record
Conditions
Amyotrophic Lateral Sclerosis ALS
Interventions
Astaxanthin, Protandim, Melatonin, MitoQ
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
2
States / cities
Durham, North Carolina • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 26, 2025 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 2 Interventional Results available

Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes

NCT00887562
View directory record Official record
Conditions
MELAS Syndrome
Interventions
Idebenone, Placebo
Drug · Other
Lead sponsor
Michio Hirano
Other
Eligibility
8 Years to 65 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 26, 2016 · Synced Oct 21, 2026, 6:31 AM EDT
Completed No phase listed Observational

Genetic and Physical Study of Childhood Nerve and Muscle Disorders

NCT01568658
View directory record Official record
Conditions
Muscular Dystrophies, Muscle Myopathies, Hereditary Spastic Paraplegias, Inherited Neuropathies, Inherited Neuromuscular Conditions
Interventions
Not listed
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eligibility
1 Day to 100 Years
Enrollment
2,586 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2012
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 20, 2026 · Synced Oct 21, 2026, 6:31 AM EDT
Completed Phase 1 Interventional

Safety Study of Idebenone to Treat Friedreich's Ataxia

NCT00015808
View directory record Official record
Conditions
Friedreich Ataxia
Interventions
Idebenone
Drug
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eligibility
Not listed
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2006
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 12, 2006 · Synced Oct 21, 2026, 6:31 AM EDT