A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)
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|ClinicalTrials.gov Identifier: NCT01377922|
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : January 4, 2018
Last Update Posted : January 4, 2018
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment|
Lambert Eaton Myasthenic Syndrome
Drug: Amifampridine Phosphate
The study was conducted at 13 clinical sites in 8 countries, including France, Germany, Hungary, Poland, Russia, Serbia, Spain, and the United States.
The study was conducted from 03Jun2011 to 08Jul2016.
|Pre-assignment Details||Open-label Run-in (Part 1): titration to the optimal amifampridine dose (well tolerated and resulted in a ≥3 point improvement in QMG score from Screening for patients without previous amifampridine use) for each individual patient. Patients who did not receive amifampridine prior to Run-in and who did not reach the optimal dose were discontinued.|