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

Expanded access is no longer available for this treatment.

Sponsor:

Information provided by (Responsible Party):

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT01373333

First received: June 13, 2011

Last updated: July 18, 2016

Last verified: July 2016

History of Changes

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:

Genetic and Rare Diseases Information Center resources: Lambert Eaton Myasthenic Syndrome

U.S. FDA Resources

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:

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
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:

Hypersensitivity to any component of this medication.
History of past or current seizures.
History of asthma.
Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the QTc interval.
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

Locations


United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44139

Sponsors and Collaborators

The Cleveland Clinic

Investigators


Principal Investigator:	Kerry H Levin, M.D.	The Cleveland Clinic

More Information


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:	July 18, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Syndrome Lambert-Eaton Myasthenic Syndrome Disease Pathologic Processes Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site Neoplasms Paraneoplastic Syndromes Autoimmune Diseases of the Nervous System Nervous System Diseases	Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases 3,4-diaminopyridine 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016

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