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Clinical trials for lisdexamfetamine dimesylate

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
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    • 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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    15 result(s) found for: lisdexamfetamine dimesylate. Displaying page 1 of 1.
    EudraCT Number: 2011-003615-28 Sponsor Protocol Number: SPD489-209 Start Date*: 2012-12-21
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 2, Multicenter, Double-blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging Efficacy and Safety Study of SPD489 in Combination with an Antidepressant...
    Medical condition: Major Depressive Disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-004457-88 Sponsor Protocol Number: SPD489-346 Start Date*: 2014-03-05
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eati...
    Medical condition: Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss beha...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-003006-25 Sponsor Protocol Number: SPD489-323 Start Date*: 2012-02-02
    Sponsor Name:Shire Development Inc.
    Full Title: The SPD489-323, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressan...
    Medical condition: Major Depressive Disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) CZ (Completed) BE (Completed) EE (Completed) FI (Completed) IT (Prematurely Ended)
    Trial results: View results
    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: 2012-003313-34 Sponsor Protocol Number: SPD489-345 Start Date*: 2013-03-28
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 3, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults with Binge Eating Disorder
    Medical condition: Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss beha...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) IT (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-001490-16 Sponsor Protocol Number: SCÄ01 Start Date*: 2017-11-13
    Sponsor Name:Stockholms läns landsting
    Full Title: Lisdexamphetamine treatment of Bulimia Nervosa with and without probable simultaneous Attention Deficit Hyperactivity Disorder (ADHD). A randomized , open, fase II-study with cross-over design.
    Medical condition: Bulimia Nervosa with and without simultaneous Attention Deficit Hyperactivity Disorder.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003018-17 Sponsor Protocol Number: SPD489-322 Start Date*: 2012-10-10
    Sponsor Name:Shire Development LLC
    Full Title: The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant...
    Medical condition: Major Depressive Disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-003019-47 Sponsor Protocol Number: SPD489-329 Start Date*: 2012-02-10
    Sponsor Name:Shire Development Inc
    Full Title: A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With R...
    Medical condition: Major Depressive Disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended) CZ (Prematurely Ended) ES (Prematurely Ended) BE (Prematurely Ended) EE (Prematurely Ended) FI (Prematurely Ended) SE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003310-14 Sponsor Protocol Number: SPD489-344 Start Date*: 2013-06-18
    Sponsor Name:Shire Development LLC
    Full Title: The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Ag...
    Medical condition: Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss beha...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003309-91 Sponsor Protocol Number: SPD489-343 Start Date*: 2013-03-20
    Sponsor Name:Shire Development, LLC
    Full Title: The SPD489-343, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Ag...
    Medical condition: Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss beha...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-011745-94 Sponsor Protocol Number: SPD489-317 Start Date*: 2009-10-19
    Sponsor Name:Shire Pharmaceutical Development Limited
    Full Title: A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel-group Study to Compare the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents...
    Medical condition: Attention Deficit/Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10003736 Attention deficit/hyperactivity disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) FR (Completed) ES (Completed) BE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020951-30 Sponsor Protocol Number: SPD489-404 Start Date*: 2011-03-03
    Sponsor Name:Shire Pharmaceutical Development Ltd
    Full Title: A Phase 4, Open-label, Multicentre, 2-Year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)
    Medical condition: Attention Deficit/Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) BE (Completed) ES (Completed) SE (Completed) PL (Completed) DE (Completed) HU (Completed) IT (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: 2008-000720-10 Sponsor Protocol Number: SPD489-326 Start Date*: 2008-11-20
    Sponsor Name:Shire Pharmaceutical Development Limited
    Full Title: A Phase III, Double- Blind, Placebo- Controlled, Randomised Withdrawal, Multicentre, Extension, Safety and Efficacy of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 with A...
    Medical condition: Attention Deficit / Hyperactivity Disorder (ADHD)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10037175 - Psychiatric disorders 10064104 ADHD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) NL (Completed) SE (Completed) BE (Completed) GB (Completed) IT (Completed) HU (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)
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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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