> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA, Catalyst Agree on Trial Protocol for LEMS Therapy
- URL: https://www.fdaweb.com/fda-catalyst-agree-on-trial-protocol-for-lems-therapy/
- Published: 2016-10-31T12:00:00.000Z
- Updated: 2026-09-14T21:43:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137218

FDA and Catalyst Pharmaceuticals have reached an agreement under a special protocol assessment for the protocol design, clinical endpoints, and statistical analysis approach in an upcoming Phase 3 study evaluating Firdapse (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome. Catalyst intends to conduct its second Phase 3 trial (designated as LMS-003) at two clinical trial sites in the U.S. The double-blind, placebo-controlled withdrawal trial will include 28 subjects, and will have the same co-primary endpoints as Catalyst’s first Phase 3 trial evaluating Firdapse, according to the company, adding that it will be a parallel design and not a cross-over design. Additionally, the agency has agreed to allow Catalyst to enroll patients from its expanded access program as study subjects.