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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Approved for marketing
CT.gov ID
NCT01825395
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 3, 4-Diaminopyridine

Study Design

Study Type:
Expanded Access
Official Title:
Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT01825395
    Other Study ID Numbers:
    • 04-0567
    First Posted:
    Apr 5, 2013
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Lambert-Eaton Myasthenic Syndrome
    Syndrome
    Amifampridine

    Study Results

    No Results Posted as of Oct 6, 2021