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

University of Colorado Denver (CU Denver)

Status

Conditions: Lambert Eaton Myasthenic Syndrome

Treatments: Drug: 3, 4-Diaminopyridine

Study type: Expanded Access

Funder types: Other

Identifiers

NCT01825395

04-0567

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.