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
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.
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Exclusion Criteria
-
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.
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Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Colorado
🇺🇸Aurora, Colorado, United States