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Clinical Trial Summary

Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome (LEMS)-related weakness.


Clinical Trial Description

The objectives of the study were to confirm the safety and to test the efficacy of 3,4-DAP in the treatment of LEMS-related weakness.

This was a phase 2 randomized double-blind placebo-controlled withdrawal study in subjects with known clinically active LEMS who had been on a chronic stable dose of compassionate distribution Jacobus 3,4-DAP provided through FDA-approved individual investigator-held INDs. ;


Study Design


Related Conditions & MeSH terms

  • Eaton-Lambert Myasthenic Syndrome
  • Lambert-Eaton Myasthenic Syndrome
  • Syndrome

NCT number NCT01511978
Study type Interventional
Source Jacobus Pharmaceutical
Contact
Status Completed
Phase Phase 2
Start date January 2012
Completion date July 2015

See also
  Status Clinical Trial Phase
No longer available NCT01373333 - Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome N/A
Completed NCT02970162 - Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS) Phase 3
Completed NCT05408702 - Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes
Recruiting NCT06441825 - Patient Observation With Environmental and Wearable Sensors in Myasthenia Gravis
Completed NCT00004832 - Randomized Study of 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome N/A
Approved for marketing NCT00872950 - 3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)
No longer available NCT00994916 - Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
No longer available NCT02189720 - Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome