Status:
APPROVED_FOR_MARKETING
Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome
Lead Sponsor:
University of Colorado, Denver
Conditions:
Lambert Eaton Myasthenic Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
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
- 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
- Is known to have a sensitivity to 3, 4-DAP,
- Has a history of:
- past or current seizures,
- cardiac arrhythmia,
- hepatic, renal or hematologic disease, or
- severe asthma,
- Is believed by the investigator to be unable to comply with the protocol.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01825395
Last Update
October 6 2021
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045