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

Sponsor: University of Colorado, Denver

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT01825395

Patient View

This clinical trial investigates the effects of 3,4-Diaminopyridine on patients with Lambert-Eaton myasthenic syndrome. Participants must be 18 or older, diagnosed with LEMS, and meet specific health criteria, including a negative pregnancy test for females and no prolonged QT syndrome. The study requires informed consent and ECG monitoring to assess drug impact.

Patient Parameters

Program Overview

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

Eligibility Criteria

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.

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