Expanded Access Study Amifampridine Phosphate in Congenital Myasthenic Syndrome (CMS) (EAP-001)
|ClinicalTrials.gov Identifier: NCT02189720|
Expanded Access Status : No longer available
First Posted : July 15, 2014
Last Update Posted : December 9, 2019
|First Submitted Date||July 5, 2014|
|First Posted Date||July 15, 2014|
|Last Update Posted Date||December 9, 2019|
|Brief Title||Expanded Access Study Amifampridine Phosphate in Congenital Myasthenic Syndrome (CMS)|
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.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|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|
|Responsible Party||Catalyst Pharmaceuticals, Inc.|
|Study Sponsor||Catalyst Pharmaceuticals, Inc.|
|PRS Account||Catalyst Pharmaceuticals, Inc.|
|Verification Date||December 2019|