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

Lambert Eaton Myasthenic Syndrome Clinical Trial

— 3 4-DAP  

Official title:

Use of 3,4-Diaminopyridine(3 4-DAP)in the Treatment of Lambert-Eaton Syndrome (LEMS)

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT01825395
• Other study ID #: 04-0567
• Status: Approved for marketing

Study information

• Verified date: September 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lambert Eaton Myasthenic Syndrome
• Lambert-Eaton Myasthenic Syndrome
• Syndrome

Intervention

Drug:
• 3, 4-Diaminopyridine

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States,