Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS) (3-4DAP)
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|ClinicalTrials.gov Identifier: NCT02090725|
Recruitment Status : Enrolling by invitation
First Posted : March 18, 2014
Last Update Posted : August 2, 2016
|Condition or disease||Intervention/treatment|
|Muscle Weakness||Drug: 3-4 Diaminopyridine|
More than half of LEMS cases are associated with malignancy, usually small cell lung cancer. These paraneoplastic cases progress more quickly than primary autoimmune LEMS. An overlap syndrome with other autoimmune diseases is often detected in LEMS patients.
3,4 DAP is effective in LEMS because it increases calcium influx into the nerve terminal by blocking potassium efflux and thereby prolonging the presynaptic action potential. 3,4 DAP is less likely to provoke epileptic seizures than its precursor, 4-aminopyridine, because it is less able to cross the blood-brain barrier. 3,4 DAP is effective in increasing strength and improving autonomic symptoms in LEMS patients of both the primary autoimmune and paraneoplastic etiologies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Controlled Trial of 3,4-Diaminopyridine in LEMS|
|Study Start Date :||February 2004|
|Estimated Primary Completion Date :||December 2020|
|Experimental: 3-4 Diaminopyridine (DAP)||
Drug: 3-4 Diaminopyridine
Other Name: 3-4 DAP
- Change in muscle weakness [ Time Frame: Month 1, Month 2, Month 3, then changing to every 6 months once patient is stable ]Muscle weakness will be assessed monthly for the first 3 months based on office visits and blood tests (complete blood count (CBC), electrolytes, glucose, liver function tests, blood urea nitrogen (BUN), creatinine). Muscle weakness will then be assessed every 6 months once the patient is stabilized based on office visits and blood tests (CBC, electrolytes, glucose, liver function tests, BUN, creatinine).
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): NCT02090725
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03221|
|Principal Investigator:||Jeffrey A. Cohen, MD||Dartmouth-Hitchcock Medical Center|