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Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Descriptive Information
Brief Title † Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine
Official Title † Treatment of Lambert-Eaton Syndrome With 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.
Study Phase N/A
Study Type † Expanded Access
Study Design †
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Lambert-Eaton Myasthenic Syndrome
Intervention † Drug3,4 diaminopyridine
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment †
Start Date †
Completion Date
Primary Completion Date
Eligibility Criteria † 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers
Contacts †† David Lacomis, MD, 412-647-1706, lacomisd@upmc.edu
Location Countries †
Administrative Information
NCT ID † NCT00994916
Organization ID IRB0410047
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † University of Pittsburgh
Collaborators †† Jacobus Pharmaceutical
Investigators † : ,
Information Provided By
Verification Date May 2017
First Received Date † October 8, 2009
Last Updated Date May 4, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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