Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome (34-DAP)
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ClinicalTrials.gov Identifier: NCT01373333 |
Expanded Access Status :
No longer available
First Posted : June 14, 2011
Last Update Posted : July 20, 2016
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Condition or disease | Intervention/treatment |
---|---|
Lambert-Eaton Myasthenic Syndrome | Drug: 3,4 DAP |
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 |

- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44139 |
Principal Investigator: | Kerry H Levin, M.D. | The Cleveland Clinic |
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 |
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 |