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Trial record 2 of 6 for:    idebenone | Duchenne Muscular Dystrophy

Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03433807
Expanded Access Status : Temporarily not available
First Posted : February 15, 2018
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Santhera Pharmaceuticals

Tracking Information
First Submitted Date February 8, 2018
First Posted Date February 15, 2018
Last Update Posted Date November 21, 2019
 
Descriptive Information
Brief Title Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)
Brief Summary The primary objective of this Expanded Access Program is to provide idebenone as a treatment for eligible participants with Duchenne Muscular Dystrophy before it is commercially available in the United States (U.S.) for the indication of DMD.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Drug: Idebenone
900 mg idebenone/day (2 tablets to be taken 3 times a day with meals)
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
Expanded Access Status Temporarily not available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03433807
Responsible Party Santhera Pharmaceuticals
Study Sponsor Santhera Pharmaceuticals
Collaborators Not Provided
Investigators Not Provided
PRS Account Santhera Pharmaceuticals
Verification Date November 2019