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Trial record 3 of 3 for:    "Leber Optic Atrophy" | "Micronutrients"

Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495715
Recruitment Status : Withdrawn
First Posted : December 20, 2011
Last Update Posted : August 22, 2014
Information provided by (Responsible Party):
Santhera Pharmaceuticals

Brief Summary:
The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.

Condition or disease Intervention/treatment Phase
Leber's Hereditary Optic Neuropathy Drug: Idebenone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants

Arm Intervention/treatment
Experimental: Idebenone Drug: Idebenone
Placebo Comparator: Placebo Drug: Placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > or equal 10 years and < 65 years
  • Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR
  • No explanation for visual loss besides LHON

Exclusion Criteria:

  • Any previous use of idebenone
  • Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
  • Previous participation in Study SNT-II-003 (RHODOS) for idebenone.

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Responsible Party: Santhera Pharmaceuticals Identifier: NCT01495715     History of Changes
Other Study ID Numbers: SNT-III-011
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Neuritis
Optic Atrophy, Hereditary, Leber
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Optic Atrophies, Hereditary
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances