Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

July 5, 2019 updated by: David Lacomis, MD
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Lacomis, MD

Collaborators

Jacobus Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 9, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB0410047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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