Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
Sponsor
Santhera Pharmaceuticals (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01495715
Collaborator
(none)
0
2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Idebenone
|
Drug: Idebenone
|
| Placebo Comparator: Placebo
|
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Santhera Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Santhera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01495715
Other Study ID Numbers:
- SNT-III-011
First Posted:
Dec 20, 2011
Last Update Posted:
Aug 22, 2014
Last Verified:
Aug 1, 2014