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Clinical trials for Evenamide

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    4 result(s) found for: Evenamide. Displaying page 1 of 1.
    EudraCT Number: 2020-000439-32 Sponsor Protocol Number: NW-3509/015/II/2019 Start Date*: 2021-04-28
    Sponsor Name:NEWRON PHARMACEUTICALS SPA
    Full Title: An open-label, multi-center, extension study to evaluate the long-term safety, tolerability and preliminary efficacy of Evenamide as add-on treatment in patients with treatment-resistant schizophre...
    Medical condition: Schizophrenia not responding adequately to current antipsychotic treatment
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10072913 Treatment-resistant schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-006062-36 Sponsor Protocol Number: NW-3509/008A/II/2020 Start Date*: 2021-06-30
    Sponsor Name:Newron Pharmaceuticals S.p.A.
    Full Title: A PHASE II/III, PROSPECTIVE, MULTI-CENTER, RANDOMIZED, 4-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY, DESIGNED TO DETERMINE THE SAFETY, TOLERABILITY, EEG EFFECTS AND EFFICACY OF ORAL DOSES OF 30 M...
    Medical condition: Chronic schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) ES (Ongoing) RO (Ongoing) HU (Completed) PL (Completed) EE (Completed) LV (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000437-41 Sponsor Protocol Number: NW-3509/014/II/2019 Start Date*: 2021-02-24
    Sponsor Name:NEWRON PHARMACEUTICALS SPA
    Full Title: A pilot, open-label, rater-blinded, randomized, parallel-group, multi-center study to evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of Evenamide in patients...
    Medical condition: Schizophrenia not responding adequately to current antipsychotic treatment
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10072913 Treatment-resistant schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002093-34 Sponsor Protocol Number: NW-3509/020/III/2021 Start Date*: 2021-11-12
    Sponsor Name:NEWRON PHARMACEUTICALS SPA
    Full Title: A Phase II/III, multi-center, open-label, extension study to determine the long-term safety, tolerability, and efficacy of evenamide in patients with psychiatric disorders who participated in a pre...
    Medical condition: Patients with psychiatric disorders who participated in a previous trial with evenamide.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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    Query did not match any studies.
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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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