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Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes With 3, 4-Diaminopyridine


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

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Trial Information

Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes With 3, 4-Diaminopyridine


Inclusion Criteria:



- Be diagnosed with LEMS or a type of CMS likely to respond to 3, 4-DAP.

- If female of childbearing age, have negative pregnancy test, and be willing to
practice and effective form of birth control during the study.

- Tested and found by ECG not to have a prolonged QTc syndrome.

- Agrees 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 or of severe asthma, or has an epileptiform
EEG.

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

- Is unable to give informed consent.

- No patient will be excluded based on race, ethnicity, gender, or HIV status

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Louis H Weimer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Food and Drug Administration

Study ID:

AAAB2528

NCT ID:

NCT01378546

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Lambert Eaton Myasthenic Syndrome (LEMS)
  • Lambert-Eaton Myasthenic Syndrome
  • Myasthenic Syndromes, Congenital

Name

Location
Columbia University Medical Center New York, New York  10032