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CLINICAL TRIALS PROFILE FOR AMIFAMPRIDINE

Clinical Trials for Amifampridine

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01377922	A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)	Completed	Catalyst Pharmaceuticals, Inc.	Phase 3	A Phase 3 study to evaluate the efficacy and safety of Amifampridine Phosphate in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
NCT02189720	Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndrome (CMS), or Downbeat Nystagmus Patients	Available	Catalyst Pharmaceuticals, Inc.	N/A	The primary objective of the study is: • To provide patients with LEMS/CMS/downbeat nystagmus access to amifampridine phosphate therapy until the product becomes commercially available. The secondary objective of the study is: • To assess the long-term safety of amifampridine phosphate in patients with LEMS/CMS/downbeat nystagmus
NCT02562066	Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes	Recruiting	Catalyst Pharmaceuticals, Inc.	Phase 3	This randomized, double-blind, controlled, outpatient two-period, two-treatment crossover study is designed to evaluate the efficacy and safety of amifampridine phosphate in patients (ages 2 and above) diagnosed with certain genetic subtypes of CMS and demonstrated open label (amifampridine phosphate) or history of sustained amifampridine benefit from treatment.
NCT02970162	Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)	Enrolling by invitation	Catalyst Pharmaceuticals, Inc.	Phase 3	This study evaluates the effect of withdrawing amifampridine phosphate treatment from patients with LEMS. One half of the patients will continue to receive amifampridine phosphate and the other half will receive placebo, during this double-blind study.
NCT03304054	Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG	Not yet recruiting	Catalyst Pharmaceuticals, Inc.	Phase 3	Efficacy and safety of amifampridine phosphate in improving the activities of daily living for patients with antibody positive MuSK myasthenia gravis.
NCT03579966	Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)	Recruiting	Catalyst Pharmaceuticals, Inc.	Phase 3	Evaluate the long-term safety of amifampridine phosphate in the symptomatic relief of antibody positive MuSK-MG.
NCT03781479	Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients	Not yet recruiting	Catalyst Pharmaceuticals, Inc.	Phase 2	A two-period, two-treatment, crossover study to evaluate the safety, tolerability and efficacy of amifampridine phosphate in ambulatory patients diagnosed with SMA Type 3.
Trial ID	Title	Status	Sponsor	Phase	Summary