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
  Purpose

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.


Condition Intervention
Lambert-Eaton Myasthenic Syndrome
Drug: 3,4 DAP

Study Type: Expanded Access     What is Expanded Access?
Official Title: Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Study Start Date: September 1997
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373333

Contacts
Contact: Sneha Ramesh 216-445-8597 rameshs@ccf.org

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44139
Contact: Sneha Ramesh    216-445-8597    rameshs@ccf.org   
Principal Investigator: Kerry H Levin, M.D.         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Kerry H Levin, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01373333     History of Changes
Obsolete Identifiers: NCT00817856
Other Study ID Numbers: 102,384
Study First Received: June 13, 2011
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lambert-Eaton Myasthenic Syndrome
Syndrome
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Disease
Immune System Diseases
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Neurodegenerative Diseases
Neuromuscular Diseases
Neuromuscular Junction Diseases
Paraneoplastic Syndromes
Paraneoplastic Syndromes, Nervous System
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014