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Randomized Study of 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome

Lambert-Eaton Myasthenic Syndrome Clinical Trial

Clinical Trial Summary

OBJECTIVES: I. Evaluate the safety and effectiveness of 3,4-diaminopyridine (DAP) in the treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS).

II. Determine the side-effects and benefits associated with DAP.

Clinical Trial Description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to receive 3,4-diaminopyridine (DAP) or placebo orally 3 times daily for 5 days, after which treatment is discontinued and patients are observed for at least 24 hours. At the end of the blinded study, patients may then elect to take open label DAP orally 3 times daily for 6 months; those who do so are monitored for clinical effects and side effects for at least 6 months. ;

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Lambert-Eaton Myasthenic Syndrome
Clinical Trial Details
NCT number NCT00004832
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase N/A
Start date August 1994
Completion date June 1998
View Details
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 NCT01511978 - Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome Phase 2
No longer available NCT02189720 - Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome
No longer available NCT00994916 - Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Approved for marketing NCT00872950 - 3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)