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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:
The Cleveland Clinic
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
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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:
Detailed Description:
-
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.
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) |
| Sexes Eligible for Study: | All |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01373333
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 |
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 June 22, 2017