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Clinical trials for Concerta

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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    27 result(s) found for: Concerta. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2011-005452-34 Sponsor Protocol Number: SPD489-406 Start Date*: 2013-08-20
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 4, Randomised, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 Compared with OROS-MPH with a Placebo Referance Arm, ...
    Medical condition: Attention-deficit/hyperactivity disorder is a psychiatric disorder characterized by developmentally inappropriate degrees of inattentiveness, impulsivity, and hyperactivity
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004873 10064104 ADHD LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended) HU (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000368-14 Sponsor Protocol Number: NCA Start Date*: 2017-12-14
    Sponsor Name:Sahlgrenska Univerisity Hospital Gothenburg
    Full Title: A head-to-head randomized clinical trial of methylphenidate and lisdexamphetamine treatment for executive functions and global functioning in adults with ADHD
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-002249-35 Sponsor Protocol Number: mkjf001 Start Date*: 2006-10-26
    Sponsor Name:Addiction Center Stockholm
    Full Title: Clinical trial of sustained release methylphenidate for Attention-Deficit-Hyperactivity-Disorder (ADHD) in adult criminal offenders with amphetamine addiction
    Medical condition: 54 male prison inmates (27 in each treatment condition) that meet the DSM-IV criteria for amphetamine addiction and for ADHD and who are servicing their prison sentence are recruited.
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2006-002553-80 Sponsor Protocol Number: ADHD Norrtälje 2006 Start Date*: 2006-11-17
    Sponsor Name:Karolinska Universitetssjukhuset
    Full Title: ADHD hos intagna inom Kriminalvården - förekomst/diagnos/behandling/uppföljning
    Medical condition: Attention Deficit Hyperactivity Disorder (ADHD)
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000730-37 Sponsor Protocol Number: 42603ATT3002 Start Date*: 2005-02-07
    Sponsor Name:Janssen-Cilag Medical Affairs EMEA
    Full Title: A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose-response phase III A study to evaluate safety and efficacy of Prolonged Release (PR) OROS methylphenidate (18, 36 a...
    Medical condition: Attention Deficit Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    10003731
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) CZ (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2008-000679-90 Sponsor Protocol Number: SPD489-325 Start Date*: 2009-04-08
    Sponsor Name:Shire Pharmaceutical Development Limited
    Full Title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and ...
    Medical condition: Attention Deficit / Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) FR (Completed) ES (Completed) NL (Completed) SE (Completed) BE (Completed) IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2014-002002-20 Sponsor Protocol Number: 2014METAL1 Start Date*: 2015-06-10
    Sponsor Name:UMCG
    Full Title: A multicentre randomized double-blind placebo controlled discontinuation trial of methylphenidate
    Medical condition: attention-deficit/hyperactivity disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001042-28 Sponsor Protocol Number: CONCERTAATT4080 Start Date*: 2015-04-24
    Sponsor Name:Ortho-McNeil Janssen Scientific Affairs LLC
    Full Title: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of CONCERTA on Older Children with ADHD (The ABC Study)
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-004037-18 Sponsor Protocol Number: 42603ATT3004 Start Date*: 2006-03-10
    Sponsor Name:Janssen-Cilag Medical Affairs EMEA
    Full Title: An Open Label, Multicentre Study to Evaluate the Long Term Safety of Prolonged Release (PR) OROS Methylphenidate (18, 36, 54, 72 and 90 mg/day) in Adults with Attention Deficit/Hyperactivity Disor...
    Medical condition: Attention Deficit-Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    7.1 10003735 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001081-26 Sponsor Protocol Number: CONCERTAATT4069 Start Date*: 2015-04-24
    Sponsor Name:Ortho-McNeil Janssen Scientific Affairs LLC
    Full Title: The ABC Study: A Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral, and Cognitive Effects of CONCERTA on Older Children with ADHD
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-002111-82 Sponsor Protocol Number: 42603ATT3013 Start Date*: 2007-10-24
    Sponsor Name:Janssen-Cilag International N.V., Turnhoutseweg 30, B-2340 Beerse, Belgium
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS® methylphenidate (54 and 72 mg/day) i...
    Medical condition: Attention Deficit-Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) SE (Completed) NL (Completed) DK (Completed) FI (Completed) BE (Completed) GB (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-001906-24 Sponsor Protocol Number: LAMA/2021/1 Start Date*: 2022-11-14
    Sponsor Name:Medical University in Lodz
    Full Title: LAMAinDiab - lisdexamphetamine vs methylphenidate for pediatric patients with ADHD and type 1 diabetes - a randomized crossover clinical trial .
    Medical condition: Patients with ADHD and type I diabetes.
    Disease: Version SOC Term Classification Code Term Level
    23.0 10037175 - Psychiatric disorders 10068453 ADHD, predominantly inattentive type LLT
    21.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000517-37 Sponsor Protocol Number: CIAOProject Start Date*: 2012-11-08
    Sponsor Name:King's College London [...]
    1. King's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: A pilot study of Concerta XL in adult offenders with ADHD
    Medical condition: Attention deficit hyperactivity disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004873 10064104 ADHD LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-020014-28 Sponsor Protocol Number: CHDR0905 Start Date*: 2010-05-11
    Sponsor Name:Centre for Human Drug Research
    Full Title: Pharmacokinetics in Plasma and Saliva of a Single Dose Immediate- or Extended Release Methylphenidate in Healthy Volunteers.
    Medical condition: N/A; pharmacokinetic study. Methylphenidate is indicated in ADHD and narcolepsia.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-011887-12 Sponsor Protocol Number: ADHS_Koenig Start Date*: 2009-10-14
    Sponsor Name:Praxis Prof. Koenig
    Full Title: Evaluation of ADHD from childhood to adolescence- impact of medical treatment on autonomic nervous system parameters
    Medical condition: ADHD is a neurobehavioral developmental disorder which affects about 5% of children. In our clinical trial designed we would like to examine whether medical treatment with stimulants has an influen...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004298-20 Sponsor Protocol Number: MAMCAC02102014 Start Date*: 2015-02-03
    Sponsor Name:Stockholm Centre for Dependency Disorders
    Full Title: The effect of methylphenidate on executive functioning in amphetamine dependent individuals with ADHD
    Medical condition: Amphetamine dependence
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001084-39 Sponsor Protocol Number: CONCERTAATT4082 Start Date*: 2015-04-24
    Sponsor Name:Janssen Korea Ltd
    Full Title: Efficacy and learning skill after OROS Methylphenidate treatment in adolescents with Attention-Deficit/Hyperactivity Disorder: A 12-week, multi-center, open-label study
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004271-78 Sponsor Protocol Number: CIAOII Start Date*: 2016-05-31
    Sponsor Name:King's College London
    Full Title: Randomised controlled trial of the short term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention deficit hyperactivity disorder
    Medical condition: Attention Deficit Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10064104 ADHD LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-003295-38 Sponsor Protocol Number: 6520-0650-07 Start Date*: 2006-03-03
    Sponsor Name:Medice Arzneimittel Pütter GmbH & Co. KG
    Full Title: Vergleich der Wirksamkeit von Medikinet retard mit Concerta bei Kindern mit ADHS
    Medical condition: Hyperkinetische Störung bzw. Aufmerksamkeitsdefizit/Hyperaktivitätsstörung (ADHS)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001217-27 Sponsor Protocol Number: CONCERTAATT4092 Start Date*: 2015-04-24
    Sponsor Name:Janssen Korea Ltd
    Full Title: An Open-label Prospective Trial to Evaluate Functional Outcomes of OROS Methylphenidate in Children with ADHD (FOSCO)
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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