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

NCT ID: NCT01825395

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

Brief Summary

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

Conditions

Lambert Eaton Myasthenic Syndrome

Interventions

3, 4-Diaminopyridine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven P Ringel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

04-0567

Identifier Type: -

Identifier Source: org_study_id