Status:
COMPLETED
Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy
Lead Sponsor:
Santhera Pharmaceuticals
Conditions:
Leber's Hereditary Optic Neuropathy
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
Brief Summary
This study is meant to assess the effectiveness of idebenone on visual function measures in patients with Leber's Hereditary Optic Neuropathy over a 6 months period.
Detailed Description
The study involves 6 clinic visits.
Eligibility Criteria
Inclusion
- Age \> or = 14 years and \< 65 years
- Impaired visual acuity in at least one eye due to LHON
- Onset of visual loss due to LHON lies five years or less prior to Baseline
- Confirmation of either G11778A, T14484C or G3460A LHON mtDNA mutations at \>60% in blood
- No explanation for the visual failure besides LHON
- Body weight ≥ 45 kg
- Negative urine pregnancy test at Screening and at Baseline (women of childbearing potential).
Exclusion
- Treatment with Coenzyme Q10 or idebenone within 1 month prior to Baseline
- Pregnancy and/or breast-feeding
- Weekly alcohol intake 35 units (men) or 24 units (women)
- Current drug abuse
- Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
- Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
- Other factor that, in the investigator's opinion, excludes the patient from entering the study
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00747487
Start Date
November 1 2007
End Date
February 1 2010
Last Update
May 27 2013
Active Locations (3)
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1
Unité de recherche clinique Ophtalmologie- Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
2
Klinikum der Universität München - Grosshadern, Neurologische Klinik und Poliklinik
Munich, Germany, 81377
3
Clinical Research Facility, 4th Floor Leazes Wing, Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP