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

• Conditions: Lambert Eaton Myasthenic Syndrome

• Registration Number: NCT01825395
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-05
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States