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Clinical trials for ory-2001

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   43861   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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    7 result(s) found for: ory-2001. Displaying page 1 of 1.
    EudraCT Number: 2018-002140-88 Sponsor Protocol Number: CL04-ORY-2001 Start Date*: 2018-09-06
    Sponsor Name:Oryzon Genomics S.A.
    Full Title: An unicenter, open-label, 1-arm, 8-week study to evaluate the efficacy, safety and tolerability of ORY-2001 in aggression in adult population with Alzheimer’s Disease (AD), Lewy Body Dementia (LBD)...
    Medical condition: Agression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001488 Aggression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-001436-54 Sponsor Protocol Number: CL06-ORY-2001 Start Date*: 2019-06-05
    Sponsor Name:Oryzon Genomics S. A.
    Full Title: A single-center, open-label, single-arm, 13-week study to evaluate the efficacy, safety and tolerability of ORY-2001 in aggression in Alzheimer’s Disease (AD) – REIMAGINE-AD
    Medical condition: Aggression in Alzheimer’s Disease (AD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-002838-23 Sponsor Protocol Number: CL02-ORY-2001MS Start Date*: 2017-10-27
    Sponsor Name:Oryzon Genomics S. A
    Full Title: Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS)...
    Medical condition: patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10063400 Secondary progressive multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-004893-32 Sponsor Protocol Number: CL03-ORY-2001 Start Date*: 2018-04-03
    Sponsor Name:Oryzon Genomics S.A.
    Full Title: A multicentre, multinational, randomised, double-blind, placebo-controlled, 3-arm, 24-week parallel-group study to evaluate the safety, tolerability and preliminary efficacy of ORY-2001 in patients...
    Medical condition: Alzheimer Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001618-39 Sponsor Protocol Number: CL08-ORY-2001_COVID-19 Start Date*: 2020-04-24
    Sponsor Name:Oryzon Genomics S. A.
    Full Title: A Phase II, randomized, open–label study to evaluate the efficacy and tolerability of treatment with vafidemstat in combination with standard of care treatment to prevent Acute Respiratory Distress...
    Medical condition: Acute Respiratory Distress Syndrome (ARDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10003083 ARDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-000350-26 Sponsor Protocol Number: CL09-ORY-2001 Start Date*: 2021-07-06
    Sponsor Name:Oryzon Genomics, S.A.
    Full Title: A double blind, randomized, placebo-controlled, adaptive 24-week Phase IIb trial to evaluate the efficacy of vafidemstat in negative symptoms and cognitive impairment associated with schizophrenia....
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003469-20 Sponsor Protocol Number: CL07-ORY-2001 Start Date*: 2020-11-06
    Sponsor Name:Oryzon Genomics S.A.
    Full Title: A double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial to evaluate the efficacy and safety of vafidemstat in an adult borderline personality disorder (BPD) population (POR...
    Medical condition: Borderline Personality Disorder (BPD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10006034 Borderline personality disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed) BG (Ongoing)
    Trial results: (No results available)
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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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