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CLINICAL TRIALS PROFILE FOR AMIFAMPRIDINE

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All Clinical Trials for Amifampridine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01377922	A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)	Completed	Catalyst Pharmaceuticals, Inc.	Phase 3	2011-06-01	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	1969-12-31	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	2016-01-01	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	2016-11-01	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.

Clinical Trial Conditions for Amifampridine

Condition Name

Condition Name for Amifampridine
Intervention	Trials
Lambert-Eaton Myasthenic Syndrome	2
Downbeat Nystagmus	1
Myasthenia Gravis, MuSK	1
Congenital Myasthenic Syndrome	1

Condition MeSH

Condition MeSH for Amifampridine
Intervention	Trials
Syndrome	4
Lambert-Eaton Myasthenic Syndrome	4
Myasthenic Syndromes, Congenital	2
Muscular Atrophy, Spinal	2

Clinical Trial Locations for Amifampridine

Trials by Country

Trials by Country for Amifampridine
Location	Trials
United States	21
Germany	2
Italy	1
Russian Federation	1
France	1

Trials by US State

Trials by US State for Amifampridine
Location	Trials
California	4
Ohio	2
Kansas	2
Texas	1
Tennessee	1

Clinical Trial Progress for Amifampridine

Clinical Trial Phase

Clinical Trial Phase for Amifampridine
Clinical Trial Phase	Trials
Phase 3	5
Phase 2	2
N/A	1

Clinical Trial Status

Clinical Trial Status for Amifampridine
Clinical Trial Phase	Trials
Enrolling by invitation	2
Not yet recruiting	2
Recruiting	2

Clinical Trial Sponsors for Amifampridine

Sponsor Name

Sponsor Name for Amifampridine
Sponsor	Trials
Catalyst Pharmaceuticals, Inc.	8

Sponsor Type

Sponsor Type for Amifampridine
Sponsor	Trials
Industry	8