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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Santhera Pharmaceuticals.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Atrophy, Hereditary, Leber
Optic Atrophies, Hereditary
Eye Diseases, Hereditary
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
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 August 19, 2014