Status:

WITHDRAWN

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

Lead Sponsor:

Santhera Pharmaceuticals

Conditions:

Leber's Hereditary Optic Neuropathy

Eligibility:

All Genders

10-65 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01495715

Last Update

August 22 2014

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