At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 38 enrolled
Drug / intervention
Amifampridine Phosphate +1 moredrug
Likely dose
Amifampridine Phosphate 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-blind, Placebo-controlled, Randomized Discontinuation Study Followed by Open-label Extension Evaluating Efficacy and Safety of Amifampridine Phosphate in Patients With Lambert-Eaton Myasthenic Syndrome (LEMS)
In Brief
A Phase 3 clinical trial evaluating Amifampridine Phosphate and Placebo for Lambert Eaton Myasthenic Syndrome. Completed, enrolled 38 participants across 14 sites in 8 countries.
Detailed Summary
A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLambert Eaton Myasthenic Syndrome
CountriesFrance, Germany, Hungary, Poland, Russia, Serbia, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionJul 2016
TodayJul 2026
First PostedJun 22, 2011
Enrollment StartJun 1, 2011
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.0 years ago
Interventions
Amifampridine Phosphatedrug
Amifampridine, 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets), for 2 weeks.
Placebodrug
Matching placebo tablets administered 3-4 times a day (to the individual patient's tablet count of active at baseline) over 2 weeks.