Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
Primary Purpose
Leber's Hereditary Optic Neuropathy
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Idebenone
Placebo
Sponsored by
About this trial
This is an interventional trial for Leber's Hereditary Optic Neuropathy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Idebenone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01495715
First Posted
December 16, 2011
Last Updated
August 21, 2014
Sponsor
Santhera Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01495715
Brief Title
Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santhera Pharmaceuticals
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leber's Hereditary Optic Neuropathy
7. Study Design
Study Phase
Phase 3
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Idebenone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Idebenone
Intervention Type
Drug
Intervention Name(s)
Placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
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.
12. IPD Sharing Statement
Learn more about this trial
Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
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