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An Expanded Access Program for Risdiplam in Participants With Spinal Muscular Atrophy (SMA)

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: NCT04256265
Expanded Access Status : Approved for marketing
First Posted : February 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date February 3, 2020
First Posted Date February 5, 2020
Last Update Posted Date October 5, 2020
 
Descriptive Information
Brief Title An Expanded Access Program for Risdiplam in Participants With Spinal Muscular Atrophy (SMA)
Brief Summary This expanded access program (EAP) will provide access to risdiplam for eligible participants with Type 1 or Type 2 spinal muscular atrophy (SMA) before it is commercially available in the United States for the indication of SMA.
Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: Risdiplam
Risdiplam will be administered orally once daily
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 Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04256265
Responsible Party Genentech, Inc.
Study Sponsor Genentech, Inc.
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date September 2020