A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)
A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Lambert Eaton Myasthenic Syndrome
Drug: Amifampridine Phosphate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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)|
- Change from Baseline Quantitative Myasthenia Gravis (QMG)at 14 days [ Time Frame: Assessment at Baseline, Day 8, and Day 14 ] [ Designated as safety issue: No ]
- Change in SGI score [ Time Frame: Assessment at Baseline, Days 8 & 14 ] [ Designated as safety issue: No ]Subject Global Impression (SGI) is a measure of changes in subject's perception of change in overall wellbeing
- Change from Baseline Timed 25 Foot Walking Test (T25FW)at 14 days [ Time Frame: Assessment at Baseline, Day 8, and Day 14 ] [ Designated as safety issue: No ]
- Change in CGI-I score [ Time Frame: Baseline, Days 8 & 14 ] [ Designated as safety issue: No ]Investigator perceived global improvement or change
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Matching placebo tablets administered 3-4 times a day over 2 weeks.
Matching number of tablets to the individual patient's tablet count of active at baseline.
Experimental: Amifampridine Phosphate
Matching amifampridine phosphate tablets, 10 mg, administered 3-4 times a day for 2 weeks.
Drug: Amifampridine Phosphate
30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets).
This multicenter, double-blind, placebo-controlled, randomized (1:1) discontinuation study is a 4 part study designed to evaluate the efficacy and safety of multiple dose administration of amifampridine phosphate in patients with LEMS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377922
|United States, Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Los Angeles, California, United States, 90095|
|Palo Alto, California, United States, 94305|
|United States, Kansas|
|Kansas City, Kansas, United States, 66160|
|United States, New York|
|New York, New York, United States, 10032|
|Lyon, France, 69677|
|Munich, Bavaria, Germany, D-80336|
|Berlin, Germany, D-10117|
|Pecs, Hungary, H-7623|
|Warsaw, Poland, 02 097|
|Moscow, Russian Federation, 125367|
|Belgrade, Serbia, 11000|
|Madrid, Spain, 28007|
|Study Director:||Charles W Gorodetzky, MD, PhD||Chief Medical Officer|