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

September 28, 2021 updated by: University of Colorado, Denver

Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)

To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

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

No

Genders Eligible for Study

All

Description

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.

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

University of Colorado, Denver

Investigators

  • Principal Investigator: Steven P Ringel, MD, University of Colorado, Denver

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

March 22, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (ESTIMATE)

April 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0567

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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