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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lambert Eaton Myasthenic Syndrome

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Trial Information

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


Inclusion Criteria:



- Be 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 past or current seizures, cardiac arrhythmia, hepatic, renal or
hematologic disease or of severe asthma.

- Is believed by the investigator to be unable to comply with the protocol.

- Is unable to give informed consent.

- Is pregnant.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effectiveness in treating weakness associated with Lambert-Eaton Myasthenic Syndrome(LEMS) based on the Medical Research Council (MRC) 12 point quantitative scale.

Outcome Description:

Treatment period for each subject depends on the availability of 3,4 -DAP through the Expanded Access program from Jacobus Pharmaceutical Company,Inc.

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Steven P Ringel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

04-0567

NCT ID:

NCT01825395

Start Date:

July 2004

Completion Date:

March 2050

Related Keywords:

  • Lambert Eaton Myasthenic Syndrome
  • Lambert-Eaton Myasthenic Syndrome

Name

Location

University of ColoradoDenver, Colorado  80217