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Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome


N/A
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 Myasthenic Syndrome


3,4-diaminopyridine (3,4-DAP) decreases symptoms of weakness in patients with LEMS, and
therefore can be used to decrease the amount of immune modulation therapy needed to provide
an equivalent degree of disease control.


Inclusion Criteria:



1. Clinical diagnosis of LEMS with or without any of the following: evidence of
underlying malignancy, presence of P/Q or N-type calcium channel antibodies,
electrodiagnostic evidence of a presynaptic defect of neuromuscular junction
transmission.None of these laboratory findings are required for inclusion in this
study.

2. P/Q and N type calcium channel antibodies are measured in the blood as a routine
laboratory test during the course of initial diagnosis, but 10-20% of patients with
LEMS do not have elevated levels of these antibodies.

Exclusion Criteria:

1. Hypersensitivity to any component of this medication.

2. History of past or current seizures.

3. History of asthma.

4. Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the
QTc interval.

5. Family history of prolonged QTc syndrome, history of unexplained syncope, seizures or
cardiac arrest.

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Kerry H Levin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

102,384

NCT ID:

NCT01373333

Start Date:

September 1997

Completion Date:

Related Keywords:

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

Name

Location

Cleveland Clinic Foundation Cleveland, Ohio  44195