A double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of patients with Leber's Hereditary Optic Neuropathy

• Conditions: eber's Hereditary Optic Neuropathy; MedDRA version: 12.1Level: LLTClassification code 10061323Term: Optic neuropathy

• Registration Number: EUCTR2006-002679-42-DE
• Lead Sponsor: Santhera Pharmaceuticals (Switzerland) Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-09
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Age >/= 14 years and < 65 years

2. Impaired visual acuity in at least one eye due to LHON

3. Onset of visual loss due to LHON lies five years or less prior to Baseline

4. Confirmation of either G11778A, T14484C or G3460A LHON mtDNA mutations at >60% in blood

5. No explanation for the visual failure besides LHON

6. Body weight = 45 kg

7. Negative urine pregnancy test at Screening (Visit 1) and at Baseline (Visit 2) (women of childbearing potential)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Treatment with Coenzyme Q10 or idebenone within 1 month prior to Baseline

2. Pregnancy and/or breast-feeding

3. Weekly alcohol intake >35 units (men) or > 24 units (women)

4. Current drug abuse

5. 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

6. Participation in another clinical trial of any investigational drug within 3 months prior to Baseline

7. Other factor that, in the investigator’s opinion, excludes the patient from entering the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified