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Generated: July 21, 2019

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CLINICAL TRIALS PROFILE FOR AMIFAMPRIDINE

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Clinical Trials for Amifampridine

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

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Clinical Trial Conditions for Amifampridine

Condition Name

Condition Name for Amifampridine
Intervention Trials
Lambert-Eaton Myasthenic Syndrome 2
Lambert Eaton Myasthenic Syndrome 1
Myasthenic Syndromes, Congenital 1
Downbeat Nystagmus 1
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Condition MeSH

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

Trials by Country

Trials by Country for Amifampridine
Location Trials
United States 21
Germany 2
Russian Federation 1
France 1
Poland 1
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Trials by US State

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

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

Sponsor Name

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

Sponsor Type for Amifampridine
Sponsor Trials
Industry 8
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