A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS) (NCT01377922) | Clinical Trial Compass
CompletedPhase 3
A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)
United States, France, Germany38 participantsStarted 2011-06
Plain-language summary
A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
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: Individuals eligible to participate in this study must meet all of the following inclusion criteria:
* ≥18 years of age
* Confirmed diagnosis of LEMS
* Normal respiratory function
* Normal swallowing function
* If receiving peripherally acting cholinesterase inhibitors a stable dose is required for at least 7 days prior to Screening.
* If receiving oral immunosuppressants a stable dose is required for at least 90 days prior to Screening.
* Negative pregnancy test for females of childbearing potential
* If sexually active, willing to use 2 acceptable methods of contraception
* Willing to perform all study procedures as physically possible.
* Willing and able to provide written informed consent after the nature of the study has been explained and prior to the start of any research-related procedures.
Exclusion Criteria: Individuals who meet any of the following exclusion criteria are not eligible to participate in the study:
* History of epilepsy or seizure.
* Known active brain metastasis.
* Use of Fampridine (4-aminopyridine), and any form of 3,4-diaminopyridine other than the IP provided, such as amifampridine base or Firdapse, during the study.
* Use of medications known to lower the epileptic threshold within 7 days or 5 half-lives.
* Use of medications which inhibit neuromuscular junction function within 7 days or 5 half-lives.
* Use of IVIG, plasmapheresis (plasma exchange), or immunoadsorption within 90 days
* Use of guanidine hydrochloride within…
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.
What they're measuring
1
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days