Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP (NCT01378546) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) With 3, 4 DAP
United StatesStarted 2005-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.