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

Santhera

Status and phase: Withdrawn; Phase 3

Conditions: Leber's Hereditary Optic Neuropathy

Treatments: Drug: Idebenone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01495715

SNT-III-011

Details and patient eligibility

About

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.

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups, including a placebo group

Idebenone

Experimental group

Treatment:

Drug: Idebenone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo