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 States38 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 range18 Years
SexALL
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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…
What they're measuring
1
Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days