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

This study is not yet open for participant recruitment.

Verified December 2011 by Santhera Pharmaceuticals

Sponsor:

Information provided by (Responsible Party):

Santhera Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01495715

First received: December 16, 2011

Last updated: December 19, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	December 16, 2011
Last Updated Date	December 19, 2011
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01495715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Leber's Hereditary Optic Neuropathy
Intervention ^ICMJE	Drug: Idebenone Drug: Placebo
Study Arm (s)	Experimental: Idebenone Intervention: Drug: Idebenone Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	10 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01495715
Other Study ID Numbers ^ICMJE	SNT-III-011
Has Data Monitoring Committee	Not Provided
Responsible Party	Santhera Pharmaceuticals
Study Sponsor ^ICMJE	Santhera Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Santhera Pharmaceuticals
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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