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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santhera Pharmaceuticals
• Treatments: Idebenone; Ubiquinone

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.