Lambert-Eaton Myasthenic Syndrome
Conditions
Keywords
Lambert-Eaton myasthenic syndrome, 3,4 diaminopyridine
Brief summary
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).
Detailed description
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. The investigator has a hold on enrolling new subjects.
Interventions
DRUG3,4 diaminopyridine
3,4 diaminopyridine up to 80 mg daily in divided doses
Sponsors
Jacobus Pharmaceutical
David Lacomis, MD
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Outcome results
None listed