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Expanded Access Study Amifampridine Phosphate in Congenital Myasthenic Syndrome (CMS) (EAP-001)

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: NCT02189720
Expanded Access Status : No longer available
First Posted : July 15, 2014
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Catalyst Pharmaceuticals, Inc.

Tracking Information
First Submitted Date July 5, 2014
First Posted Date July 15, 2014
Last Update Posted Date December 9, 2019
 
Descriptive Information
Brief Title Expanded Access Study Amifampridine Phosphate in Congenital Myasthenic Syndrome (CMS)
Brief Summary

The primary objective of the study is:

• To provide patients with CMSaccess to amifampridine phosphate therapy until the product becomes commercially available or development is discontinued.

The secondary objective of the study is:

• To assess the long-term safety of amifampridine phosphate in patients with CMS

Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: Amifampridine Phosphate

Dosage form: tablets containing the equivalent of 10 mg amifampridine per tablet.

Amifampridine Phosphateis given based on Investigator assessment of optimal neuromuscular benefit. Doses range from 30 mg to 80 mg, divided into doses taken 3 to 4 times per day, with a maximum single dose of 20 mg.

Other Names:
  • 3,4-Diaminopyridine Phosphate
  • 3,4 DAP
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 No longer 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 NCT02189720
Responsible Party Catalyst Pharmaceuticals, Inc.
Study Sponsor Catalyst Pharmaceuticals, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Perry Shieh, MD, PhD University of California, Los Angeles
PRS Account Catalyst Pharmaceuticals, Inc.
Verification Date December 2019