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Clinical trials for Paliperidone palmitate

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   44335   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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    17 result(s) found for: Paliperidone palmitate. Displaying page 1 of 1.
    EudraCT Number: 2011-004889-15 Sponsor Protocol Number: R092670PSY3011 Start Date*: 2012-04-23
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    16.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) BE (Completed) DE (Completed) PT (Completed) AT (Completed) SE (Completed) DK (Prematurely Ended) SK (Completed) FI (Completed) GR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-001845-40 Sponsor Protocol Number: R092670-PSY-3005 Start Date*: 2005-08-24
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Subjects With Schizophrenia
    Medical condition: Schizophrenia according to DSM-IV-TM [disorganized type (295.10), catatonic type (295.20), paranoid type (295.30), residual type (295.60) or undifferentiated type (295.90)]
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-002694-22 Sponsor Protocol Number: R092670PSY3002 Start Date*: 2005-02-07
    Sponsor Name:Janssen-Cilag International N.V
    Full Title: A Randomized, Double-Blind, Parallel Group Non-inferiority Study of Flexibly Dosed Paliperidone Palmitate(25, 50, 75, 100 mg eq) Administered Every 4 weeks and Flexibly Dosed Risperdal Consta (25, ...
    Medical condition: schizophrenia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed) SE (Completed) CZ (Completed) DK (Completed) EE (Completed) ES (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004835-10 Sponsor Protocol Number: R092670SCH3015 Start Date*: 2016-03-23
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients with Schizophrenia Previously Stabilized on the Pa...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    18.1 10037175 - Psychiatric disorders 10039636 Schizophrenia simple PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) DE (Completed) ES (Completed) DK (Completed) GR (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004676-11 Sponsor Protocol Number: R092670-PSY-3012 Start Date*: 2012-08-30
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects with Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    19.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Completed)
    Trial results: View results
    EudraCT Number: 2009-018022-30 Sponsor Protocol Number: R092670SCH3010 Start Date*: 2010-11-05
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A 6-month, open label, prospective, multicenter, international, exploratory study of a transition to flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully ...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) DE (Completed) NL (Completed) BE (Completed) ES (Completed) GB (Completed) SE (Completed) DK (Completed) IT (Completed) LV (Completed) AT (Completed) EE (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001941-28 Sponsor Protocol Number: R092670PSY3015 Start Date*: 2018-02-28
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6 Month Formulation.
    Medical condition: 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) ES (Completed) CZ (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-002247-16 Sponsor Protocol Number: R092670SCH3005 Start Date*: 2010-03-10
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmit...
    Medical condition: Recently diagnosed (1-5 years since diagnosis) schizophrenia.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10039626 Schizophrenia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) HU (Completed) ES (Completed) LT (Completed) BE (Completed) FR (Completed) EE (Completed) IT (Completed) BG (Completed) AT (Completed) GB (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2006-006434-17 Sponsor Protocol Number: R092670PSY3007 Start Date*: 2007-05-03
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palm...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Completed)
    Trial results: View results
    EudraCT Number: 2009-017271-17 Sponsor Protocol Number: R092670-SCA-3004 Start Date*: 2010-10-29
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder
    Medical condition: Schizoaffective Disorder
    Disease: Version SOC Term Classification Code Term Level
    13.1 10037175 - Psychiatric disorders 10039621 Schizoaffective disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-003560-62 Sponsor Protocol Number: R092670PSY3006 Start Date*: 2007-03-28
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects with Schi...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039626 Schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) EE (Completed) LT (Completed) DE (Completed) AT (Completed) FR (Completed) CZ (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-002785-12 Sponsor Protocol Number: 14724A Start Date*: 2013-03-20
    Sponsor Name:H. Lundbeck A/S
    Full Title: A 28-week, randomised, open-label study evaluating the effectiveness of aripiprazole once-monthly versus paliperidone palmitate in adult patients with schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    16.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) IT (Completed) DE (Completed) ES (Completed) CZ (Completed) EE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-007800-27 Sponsor Protocol Number: R092670-SCH-3004 Start Date*: 2009-10-15
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate with Oral Risperidone in Adults with Recently-Diagnosed Schizophrenia...
    Medical condition: Recently-Diagnosed Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039626 Schizophrenia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004532-30 Sponsor Protocol Number: R092670PSY3016 Start Date*: 2019-08-09
    Sponsor Name:Janssen-Cilag International NV
    Full Title: Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
    Medical condition: 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: PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002765-30 Sponsor Protocol Number: ABR49490 Start Date*: 2015-06-12
    Sponsor Name:EGRIS
    Full Title: European Long-acting Antipsychotics in Schizofrenia Trial EULAST
    Medical condition: Schizophrenia ICD-10 code F20
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) AT (Completed) IT (Completed) NO (Completed) BE (Completed) ES (Completed) DK (Completed) HU (Completed) RO (Suspended by CA) CZ (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2016-003435-38 Sponsor Protocol Number: ACP-103-035 Start Date*: 2017-04-28
    Sponsor Name:ACADIA Pharmaceuticals Inc.
    Full Title: A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of 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: HU (Prematurely Ended) ES (Ongoing) BG (Prematurely Ended) CZ (Completed) DE (Prematurely Ended) LT (Completed) PL (Prematurely Ended) IT (Prematurely Ended) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003343-29 Sponsor Protocol Number: ACP-103-064 Start Date*: 2019-11-15
    Sponsor Name:ACADIA Pharmaceuticals Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE 2)
    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: CZ (Completed) PL (Completed) HU (Completed) BG (Completed) ES (Ongoing) LT (Completed) IT (Completed) HR (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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