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

This study is not yet open for participant recruitment.
Verified December 2011 by Santhera Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Santhera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01495715
First received: December 16, 2011
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Leber's Hereditary Optic Neuropathy
 Drug: Idebenone
Drug: Placebo
 Phase 3

Study Type: Interventional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santhera Pharmaceuticals:

Arms Assigned Interventions
Experimental: Idebenone Drug: Idebenone
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Santhera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01495715     History of Changes
Other Study ID Numbers: SNT-III-011
Study First Received: December 16, 2011
Last Updated: December 19, 2011
Health Authority: United States: Food and Drug Administration

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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013