Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

• Sponsor: David Lacomis, MD (Other)
• Overall Status: No longer available
• CT.gov ID: NCT00994916
• Collaborator: Jacobus Pharmaceutical (Industry)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lambert-Eaton Myasthenic Syndrome	Drug: 3,4 diaminopyridine

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.

Study Design

• Study Type: Expanded Access
• Official Title: Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• David Lacomis, MD
• Jacobus Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Lacomis, MD, Professor of Neurology and Pathology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00994916
• Other Study ID Numbers: IRB0410047
• First Posted: Oct 14, 2009
• Last Update Posted: Jul 9, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by David Lacomis, MD, Professor of Neurology and Pathology, University of Pittsburgh: Lambert-Eaton myasthenic syndrome; 3,4 diaminopyridine
• Additional relevant MeSH terms: Lambert-Eaton Myasthenic Syndrome; Syndrome; Amifampridine

Study Results

No Results Posted as of Jul 9, 2019