Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON) | NCT01495715 | Trialant
WithdrawnInterventionalPhase 3Updated Aug 22, 2014
Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
ClinicalTrials.gov ID
NCT01495715
Lead Sponsor
Santhera PharmaceuticalsINDUSTRY
Overall Status
Withdrawn
Study Type
Interventional
Phase
Phase 3
Enrollment
0Actual
Last Update Posted
Aug 22, 2014Estimated
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.
Leber's Hereditary Optic Neuropathy
Idebenone
Placebo
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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.