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

NCT01495715 | Withdrawn Phase 3

• 1 other identifier: SNT-III-011
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Leber's Hereditary Optic Neuropathy

Study Arms (2)

Idebenone

EXPERIMENTAL

Drug: Idebenone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Idebenone DRUG

Idebenone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santhera Pharmaceuticals: lead

MeSH Terms

Conditions

Optic Atrophy, Hereditary, Leber

Interventions

idebenone

Condition Hierarchy (Ancestors)

Optic Atrophies, Hereditary; Optic Atrophy; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Eye Diseases, Hereditary; Eye Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 20, 2011
• Last Updated: August 22, 2014

Record last verified: 2014-08