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Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy

NCT00747487 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2013-05-27

No results posted yet for this study

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.

Conditions

  • Leber's Hereditary Optic Neuropathy

Interventions

DRUG

Idebenone

Idebenone 900 mg/day

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Prof Patrick F Chinnery, MD · Clinical Research Facility, 4th Floor Leazes Wing, Royal Victoria Infirmary

  • Prof Thomas Klopstock, MD · Klinikum der Universität München - Grosshadern, Neurologische Klinik und Poliklinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Canada
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00747487 on ClinicalTrials.gov