Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP

Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes With 3, 4-Diaminopyridine

NCT01378546•Louis H. Weimer, MD

Summary

Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells. 3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS as it increases strength and improves autonomic symptoms in LEMS patients. It is not currently approved by the FDA for use in the United States. The investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University MDA/ALS Research Center.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be diagnosed with LEMS or a type of CMS likely to respond to 3, 4-DAP.
•If female of childbearing age, have negative pregnancy test, and be willing to practice and effective form of birth control during the study.
•Tested and found by ECG not to have a prolonged QTc syndrome.
•Agrees 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 past or current seizures or of severe asthma, or has an epileptiform EEG.
•Is believed by the investigator to be unable to comply with the protocol.
•Is unable to give informed consent.
•No patient will be excluded based on race, ethnicity, gender, or HIV status

Locations (1)

Columbia University Medical Center

New York, New York, United States

Key Dates

Start Date

May 1, 2005

Primary Completion Date

May 1, 2015

Last Updated

July 18, 2013

Conditions

Lambert Eaton Myasthenic Syndrome (LEMS)

Interventions

3,4-diaminopyridine

DRUG

A Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)

NCT07075627

Small Cell Lung Cancer ( SCLC )Lambert Eaton Myasthenic Syndrome (LEMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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