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Clinical trials for Amifampridine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    9 result(s) found for: Amifampridine. Displaying page 1 of 1.
    EudraCT Number: 2021-004110-20 Sponsor Protocol Number: 78666 Start Date*: 2022-10-12
    Sponsor Name:Leiden University Medical Center
    Full Title: Improving symptomatic treatment with pyridostigmine and amifampridine: a randomized double-blinded, placebo controlled crossover trial in patients with myasthenia gravis (IMPACT-MG)
    Medical condition: Myasthenia Gravis
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004852 10085562 AChR myasthenia gravis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000358-23 Sponsor Protocol Number: CMS-001 Start Date*: 2019-02-06
    Sponsor Name:CATALYST PHARMACEUTICALS INC.
    Full Title: A phase 3, multicenter, double-blind, placebo-controlled, randomized, outpatient two-period two-treatment crossover study to evaluate the efficacy and safety of amifampridine phosphate (3,4 diamino...
    Medical condition: Congenital myasthenic syndromes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028424 Myasthenic syndrome PT
    20.0 10029205 - Nervous system disorders 10028425 Myasthenic syndromes in diseases classified elsewhere LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004018-25 Sponsor Protocol Number: MSK-002 Start Date*: 2018-02-22
    Sponsor Name:CATALYST PHARMACEUTICALS INC.
    Full Title: A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients with MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Pos...
    Medical condition: MuSK antibody positive myasthenia gravis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028417 Myasthenia gravis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000160-28 Sponsor Protocol Number: SMA-002 Start Date*: 2018-11-06
    Sponsor Name:CATALYST PHARMACEUTICALS INC.
    Full Title: Long term safety study of amifampridine phosphate in ambulatory patients with Spinal Muscular Atrophy (SMA) type 3
    Medical condition: Spinal Muscular Atrophy (SMA) Type 3
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003127-62 Sponsor Protocol Number: MuSK-001 Start Date*: 2015-10-02
    Sponsor Name:FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    Full Title: A Randomized, Placebo-Controlled, Pilot Crossover Study to Evaluate the Effect of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Patients with MuSK Antibody Positive Myasthenia Gravis
    Medical condition: Patients with MuSK Antibody Positive Myasthenia Gravis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004859 10062976 Neuromuscular weakness LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-004777-14 Sponsor Protocol Number: MSK-003 Start Date*: 2018-06-05
    Sponsor Name:CATALYST PHARMACEUTICALS INC.
    Full Title: Long term safety study of amifampridine phosphate in patients with MuSK antibody positive and AChR antibody positive myasthenia gravis patients
    Medical condition: MuSK antibody and AChR antibody positive myasthenia gravis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028417 Myasthenia gravis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-021850-20 Sponsor Protocol Number: LMS-002 Start Date*: 2011-09-26
    Sponsor Name:Catalyst Pharmaceutical Partners, Inc.
    Full Title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Randomized Discontinuation Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Amifampridine Phosphate (...
    Medical condition: Lambert-Eaton Myasthenic Syndrome (LEMS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10067685 Lambert-Eaton myasthenic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Prematurely Ended) HU (Completed) CZ (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004600-22 Sponsor Protocol Number: SMA-001 Start Date*: 2018-04-04
    Sponsor Name:CATALYST PHARMACEUTICALS INC.
    Full Title: A Randomized, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients with Spinal Muscular Atrophy (SMA) Type 3
    Medical condition: Spinal Muscular Atrophy (SMA) Type 3
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002405-64 Sponsor Protocol Number: CMS-002 Start Date*: 2019-05-06
    Sponsor Name:CATALYST PHARMACEUTICALS INC.
    Full Title: Long term safety study of amifampridine phosphate in patients with Congenital Myasthenic Syndromes (CMS)
    Medical condition: Congenital Myasthenic Syndromes (CMS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028424 Myasthenic syndrome PT
    20.0 10029205 - Nervous system disorders 10028425 Myasthenic syndromes in diseases classified elsewhere LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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