Clinical Trial: Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndrome (CMS), or Downbeat Nystagmus Patients
Study Status: Available
Recruit Status: Available
Study Type: Expanded Access
Official Title: An Open-Label, Expanded Access Protocol for Amifampridine Phosphate Treatment in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndrome (CMS) and Downbeat Nystagmus
Brief Summary:
The primary objective of the study is:
• To provide patients with LEMS/CMS/downbeat nystagmus access to amifampridine phosphate therapy until the product becomes commercially available.
The secondary objective of the study is:
• To assess the long-term safety of amifampridine phosphate in patients with LEMS/CMS/downbeat nystagmus
Detailed Summary:
Sponsor: Catalyst Pharmaceuticals, Inc.
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Catalyst Pharmaceuticals, Inc.
Dates:
Date Received: July 5, 2014
Date Started:
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017