Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome

Descriptive Information
Brief Title † Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome
Official Title † Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)
Brief Summary To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).
Detailed Description
Study Phase Phase 3
Study Type † Expanded Access
Study Design † N/A
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 † July 2004
Completion Date March 2050
Primary Completion Date February 2050
Eligibility Criteria † Inclusion Criteria: - Age 18 years or older, - Diagnosed with LEMS, - If female, have a negative pregnancy test, and - If premenopausal, be willing to practice an effective form of birth control during the study, - Tested and found by ECG not to have a prolonged QT syndrome, - Agree to have a second ECG at the time of peak drug effect, - Has understood and signed the Informed Consent. Exclusion Criteria: - Is known to have a sensitivity to 3, 4-DAP, - Has a history of: 1. past or current seizures, 2. cardiac arrhythmia, 3. hepatic, renal or hematologic disease, or 4. severe asthma, - Is believed by the investigator to be unable to comply with the protocol.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Kathy Ales, 609-921-7447
Location Countries † United States
Administrative Information
NCT ID † NCT01825395
Organization ID 04-0567
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † University of Colorado, Denver
Collaborators ††
Investigators † Principal Investigator: Steven P Ringel, MD, University of Colorado, Denver
Information Provided By
Verification Date December 2016
First Received Date † March 22, 2013
Last Updated Date December 21, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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