Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome (34-DAP)

Expanded access is currently available for this treatment.
Verified June 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01373333
First received: June 13, 2011
Last updated: June 16, 2014
Last verified: June 2014

June 13, 2011
June 16, 2014
September 1997
September 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01373333 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome
Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome

Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with LEMS and hopefully will decrease the need for prednisone and all other therapies that were previously required to control symptoms. How long a patient will take 3,4 DAP depends upon if he/she is seeing benefits from the medication or experiencing side effects that will prevent them from continuation in the study.

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.

Expanded Access
Not Provided
Not Provided
Lambert-Eaton Myasthenic Syndrome
Drug: 3,4 DAP
Recommended maximum dosage: 20mg four times daily and if needed an additional 20 mg per day for a total of 100 mg per day. Drug must be kept refrigerated at all times.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
Not Provided
Not Provided
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Sneha Ramesh 216-445-8597 rameshs@ccf.org
United States
 
NCT01373333
102,384
Not Provided
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Kerry H Levin, M.D. The Cleveland Clinic
The Cleveland Clinic
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP