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Clinical trials for Marinus

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   43857   clinical trials with a EudraCT protocol, of which   7284   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: Marinus. Displaying page 1 of 1.
    EudraCT Number: 2015-001324-36 Sponsor Protocol Number: 1042-900 Start Date*: 2015-06-05
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children with PCDH19 Female Pediatric Epilepsy
    Medical condition: PCDH19 Female Pediatric Epilepsy (FPE)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Children, Under 18 Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-003441-38 Sponsor Protocol Number: 1042-TSC-3001 Start Date*: Information not available in EudraCT
    Sponsor Name:Marinus Pharmaceuticals Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)
    Medical condition: Tuberous Sclerosis Complex (TSC)-related epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Ongoing) ES (Ongoing) IT (Ongoing) BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004496-12 Sponsor Protocol Number: 1042-PCDH19-3002 Start Date*: 2019-09-26
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment
    Medical condition: protocadherin 19 (PCDH19)-related epilepsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032061 Other forms of epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Female
    Trial protocol: FR (Completed) NL (Prematurely Ended) PL (Completed) HU (Completed) GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2018-001180-23 Sponsor Protocol Number: 1042-CDD-3001 Start Date*: 2018-12-06
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults with Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed b...
    Medical condition: Treatment of seizures in children and young adults with genetically confirmed cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Ongoing) FR (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004363-21 Sponsor Protocol Number: 1042-0603 Start Date*: 2015-03-11
    Sponsor Name:Marinus Pharmaceuticals, Inc
    Full Title: A Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Determine the Efficacy and Safety of Ganaxolone as Adjunctive Therapy for Adults with Drug-Resistant Partial-Onset Seizures Foll...
    Medical condition: Drug-Resistant Epilepsy with Partial-Onset Seizures
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10065336 Partial epilepsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) DE (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-002145-22 Sponsor Protocol Number: NCAG 5707 Start Date*: 2008-07-07
    Sponsor Name:NeuroCode AG
    Full Title: Klinische Untersuchung zur Verträglichkeit und Wirksamkeit nach Umstellung von Selegilin auf Rasagilin bei Patienten mit Morbus Parkinson und Schlafstörungen. Prospektive, offene, explorative Stud...
    Medical condition: Parkinsonpatienten, die bezüglich ihrer motorischen Tagesaktivität optimal eingestellt sind, leiden trotzdem vermehrt unter Tagesmüdigkeit und Schlafstörungen (Chaudhuri, 2002). Es wird angenommen...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-004286-33 Sponsor Protocol Number: 1042-0501 Start Date*: 2007-05-11
    Sponsor Name:Marinus Pharmceuticals, Inc.
    Full Title: An open-label clinical study to evaluate the safety and antiepileptic activity of ganaxolaone in treatment of patients diagnosed with infantile spasms.
    Medical condition: Infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021750 Infantile spasms LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-000251-89 Sponsor Protocol Number: 1042-0800 Start Date*: 2014-10-22
    Sponsor Name:Antwerp University Hospital
    Full Title: A controlled double-blind crossover trial of ganaxolone in children with fragile X syndrome
    Medical condition: behavioral problems in children with fragile X syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10017324 Fragile X syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-004285-13 Sponsor Protocol Number: 1042-0500 Start Date*: 2007-05-11
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A double-blind, placebo-controlled, dose-ranging clinical study to evaluate the safety, tolerability, and antiepileptic activity of ganaxolone in treatment of patients with infantile spasms.
    Medical condition: Infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021750 Infantile spasms LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    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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