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

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ClinicalTrials.gov Identifier: NCT01495715
Recruitment Status : Withdrawn
First Posted : December 20, 2011
Last Update Posted : August 22, 2014
Sponsor:
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

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


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




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

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.

Responsible Party: Santhera Pharmaceuticals
ClinicalTrials.gov 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:
Optic Nerve Diseases
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
Idebenone
Ubiquinone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances