Status:
APPROVED_FOR_MARKETING
3,4-Diaminopyridine Use in Lambert-Eaton Myasthenic Syndrome(LEMS) and Congenital Myasthenic Syndromes (CMS)
Lead Sponsor:
Lahey Clinic
Conditions:
Lambert-Eaton Myasthenic Syndrome
Congenital Myasthenic Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenic Syndr...
Detailed Description
This is an open-label, non-randomized, non-comparative expanded access study. Up to 25 patients with clinically proven paraneoplastic or primary autoimmune LEMS per EMG and positive voltage-gated calc...
Eligibility Criteria
Inclusion
- LEMS diagnosis OR Pre or Post Synaptic CMS diagnosis
- 18 years or older
- Females must have negative pregnancy test and be willing to practice an effective form of birth control
- No prolonged QT syndrome as indicated by baseline EKG
Exclusion
- Known sensitivity to 3,4-DIAMINOPYRIDINE
- History of seizures and/or severe asthma
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00872950
Last Update
April 11 2022
Active Locations (1)
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1
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805