Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Lambert-Eaton Myasthenic Syndrome
Both
Lambert-Eaton Myasthenic Syndrome
Trial Information
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll
if they are medically stable. They may receive 3,4 diaminopyridine in addition to other
treatments and standard of care investigations for LEMS under supervision of the primary
investigator. Safety laboratory studies and EKGs will be obtained.
The study has been approved by the University of Pittsburgh IRB. There is a local
Data-Safety Monitoring Board.
Inclusion Criteria:
1. Diagnosis of LEMS
2. Over 18 years old
3. Medically stable
4. If female and premenopausal, have a negative urine pregnancy test prior to starting
the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth
control such as "double-barrier contraception" during the study
Exclusion Criteria:
1. Known sensitivity to 3,4 DAP
2. History of past or current seizures
3. History of severe asthma
4. Believed by the investigator to be unable to comply with the protocol
5. Unable to provide informed consent
Type of Study:
Expanded Access
Study Design:
N/A
Authority:
United States: Food and Drug Administration
Study ID:
IRB0410047
NCT ID:
NCT00994916
Start Date:
Completion Date:
Related Keywords:
- Lambert-Eaton Myasthenic Syndrome
- Lambert-Eaton myasthenic syndrome
- 3,4 diaminopyridine
- Lambert-Eaton Myasthenic Syndrome
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