Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP
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ClinicalTrials.gov Identifier: NCT01378546 |
Recruitment Status
:
No longer available
First Posted
: June 22, 2011
Last Update Posted
: July 18, 2013
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Lambert Eaton Myasthenic Syndrome (LEMS) is rare neurological disorder that results in muscle weakness and limited reflex activity. More than half of LEMS cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells.
3,4diaminopyridine (3,4DAP)is a drug that has been demonstrated to be effective in treating the weakness associated with LEMS as it increases strength and improves autonomic symptoms in LEMS patients. It is not currently approved by the FDA for use in the United States. The investigators plan to use 3,4DAP to treat patients with LEMS here at the Columbia University MDA/ALS Research Center.
Condition or disease | Intervention/treatment |
---|---|
Lambert Eaton Myasthenic Syndrome (LEMS) | Drug: 3,4-diaminopyridine |
Study Type : | Expanded Access |
Official Title: | Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes With 3, 4-Diaminopyridine |
Study Start Date : | May 2005 |
Estimated Primary Completion Date : | May 2015 |

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Drug: 3,4-diaminopyridine

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be diagnosed with LEMS or a type of CMS likely to respond to 3, 4-DAP.
- If female of childbearing age, have negative pregnancy test, and be willing to practice and effective form of birth control during the study.
- Tested and found by ECG not to have a prolonged QTc syndrome.
- Agrees to have a second ECG at the time of peak drug effect. Has understood and signed the Informed Consent.
Exclusion Criteria:
- Is known to have a sensitivity to 3, 4-DAP.
- Has a history of past or current seizures or of severe asthma, or has an epileptiform EEG.
- Is believed by the investigator to be unable to comply with the protocol.
- Is unable to give informed consent.
- No patient will be excluded based on race, ethnicity, gender, or HIV status

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): NCT01378546
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Louis H Weimer, MD | Columbia University |
Responsible Party: | Louis H. Weimer, MD, Clinical Professor of Neurology, Columbia University |
ClinicalTrials.gov Identifier: | NCT01378546 History of Changes |
Other Study ID Numbers: |
AAAB2528 |
First Posted: | June 22, 2011 Key Record Dates |
Last Update Posted: | July 18, 2013 |
Last Verified: | July 2013 |
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 |