Clinical Trial: Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 3, Double-Blind, Placebo-controlled, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasth
Brief Summary: This study evaluates the effect of withdrawing amifampridine phosphate treatment from patients with LEMS. One half of the patients will continue to receive amifampridine phosphate and the other half will receive placebo, during this double-blind study.
Detailed Summary:
Sponsor: Catalyst Pharmaceuticals, Inc.
Current Primary Outcome:
- Quantitative Myasthenia Gravis (QMG) score [ Time Frame: change from baseline in QMG score at end of day 4 ]
- Subject Global Impression (SGI) score [ Time Frame: change from baseline in SGI score at end of day 4 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinician's Global Impression of Improvement (CGI-I) [ Time Frame: change from baseline in CGI-I score at end of day 4 ]
Original Secondary Outcome: Same as current
Information By: Catalyst Pharmaceuticals, Inc.
Dates:
Date Received: November 16, 2016
Date Started: November 2016
Date Completion: September 2017
Last Updated: January 11, 2017
Last Verified: January 2017
