At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
Continuous 3,4-DAP +1 moredrug
Likely dose
Not stated in 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.
Inpatient Double-Blind Placebo-Controlled Withdrawal Study of 3,4-Diaminopyridine Base (3,4-DAP) in Subjects With Known Lambert-Eaton Myasthenic Syndrome
In Brief
A Phase 2 clinical trial evaluating Continuous 3,4-DAP and Taper 3,4-DAP to Placebo for Lambert-Eaton Myasthenic Syndrome and Eaton-Lambert Myasthenic Syndrome. Completed, enrolled 32 participants across 7 sites.
Detailed Summary
Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome (LEMS)-related weakness.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionFeb 2014
Study CompletionJul 2015
TodayJul 2026
First PostedJan 19, 2012
Enrollment StartJan 1, 2012
Primary CompletionFeb 1, 2014
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.5 years ago
Interventions
Continuous 3,4-DAPdrug
Subjects were maintained on their usual personal dose and schedule of 3,4-DAP base
Taper 3,4-DAP to Placebodrug
Subjects were tapered over 3 days from their usual regimen of 3,4-DAP base to placebo with up to an additional 16 hours of placebo before resuming their usual pre-study regimen of 3,4-DAP base