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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01373333
Expanded Access Status : No longer available
First Posted : June 14, 2011
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Lambert-Eaton Myasthenic Syndrome Drug: 3,4 DAP

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.
Study Design
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Study Type : Expanded Access
Official Title: Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome
Study Start Date : September 1997
Estimated Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine


Interventions
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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.
Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373333


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44139
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Kerry H Levin, M.D. The Cleveland Clinic
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01373333    
Obsolete Identifiers: NCT00817856
Other Study ID Numbers: 102,384
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Lambert-Eaton Myasthenic Syndrome
Syndrome
Disease
Pathologic Processes
Myasthenia Gravis
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
Amifampridine
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action