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Clinical trials for Adolescent development

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    167 result(s) found for: Adolescent development. Displaying page 1 of 9.
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    EudraCT Number: 2015-004889-28 Sponsor Protocol Number: FFR113342 Start Date*: 2016-12-21
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent...
    Medical condition: Rhinitis, Allergic, Perennial
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-005830-63 Sponsor Protocol Number: 0485-CL-0004 Start Date*: 2009-10-30
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects with Moderate to Severe Psoriasis
    Medical condition: Moderate to severe chronic plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037153 Psoriasis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) LV (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000038-20 Sponsor Protocol Number: NN8022-3967 Start Date*: 2012-12-12
    Sponsor Name:Novo Nordisk A/S
    Full Title: A randomised, double-blind, placebo-controlled trial to assess safety, tolerability and pharmacokinetics of liraglutide in obese adolescent subjects aged 12 to 17 years
    Medical condition: Obesity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10029883 Obesity PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004874-13 Sponsor Protocol Number: AUG102821 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline
    Full Title: An open label study to determine the pharmacokinetic profiles of amoxicillin and clavulanate in adolescent patients weighing at least 40kg and no more than 16 years of age receiving AUGMENTIN™XR ...
    Medical condition: acute bacterial sinusitis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004870-14 Sponsor Protocol Number: LOC114220 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate 1mg twice daily compared with...
    Medical condition: Asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004899-35 Sponsor Protocol Number: 331-201-00191 Start Date*: 2024-06-13
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectru...
    Medical condition: Irritability Associated With Autism Spectrum Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000723-40 Sponsor Protocol Number: 331-201-00148 Start Date*: 2024-06-13
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
    Medical condition: Irritability Associated With Autism Spectrum Disorder (ASD)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-014368-20 Sponsor Protocol Number: CNTO1275PSO3006 Start Date*: 2011-01-06
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-t...
    Medical condition: Moderate to Severe Plaque-type Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) SE (Completed) PT (Completed) FR (Completed) BE (Completed) HU (Completed) GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002217-59 Sponsor Protocol Number: 63623872FLZ3002 Start Date*: 2018-05-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, ...
    Medical condition: Influenza A Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10022002 Influenza A virus infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (Prematurely Ended) LV (Prematurely Ended) EE (Completed) LT (Prematurely Ended) FR (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) SK (Prematurely Ended) HU (Prematurely Ended) BE (Completed) BG (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002156-84 Sponsor Protocol Number: 63623872FLZ3001 Start Date*: 2018-05-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, a...
    Medical condition: Influenza A Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10022002 Influenza A virus infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) LV (Prematurely Ended) LT (Prematurely Ended) FR (Prematurely Ended) DE (Prematurely Ended) SK (Prematurely Ended) BE (Completed) CZ (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) HU (Prematurely Ended) BG (Prematurely Ended) PL (Prematurely Ended) GB (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-018911-13 Sponsor Protocol Number: 31-09-267 Start Date*: 2011-06-14
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients with Schizophrenia...
    Medical condition: Schizophrenia in Adolescent Patients or Child and Adolescent Patients with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    14.1 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) BG (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001889-15 Sponsor Protocol Number: RD.06.SPR.118163 Start Date*: 2020-09-02
    Sponsor Name:Galderma S.A.
    Full Title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) EE (Ongoing) LV (Trial now transitioned) PL (Trial now transitioned) LT (Trial now transitioned) GB (GB - no longer in EU/EEA) AT (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003516-39 Sponsor Protocol Number: BUL-3/EER Start Date*: 2021-04-28
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment...
    Medical condition: Maintenance of remission in eosinophilic esophagitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10064220 Eosinophilic esophagitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001878-18 Sponsor Protocol Number: MK8962-043 Start Date*: 2017-07-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (corifollitropin alfa) in Combination with human Chorionic Gonadotropin (hCG) for Initiat...
    Medical condition: Treatment of adolescent males 14 to <18 years old with HH
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004860 10021012 Hypogonadotrophic hypogonadism LLT
    Population Age: Adolescents, Under 18 Gender: Male
    Trial protocol: IT (Completed) DK (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001681-15 Sponsor Protocol Number: TAK-390MR_207 Start Date*: 2012-10-17
    Sponsor Name:Takeda Global Research & Development Centre (Europe) Ltd
    Full Title: A Phase 2 Multicenter, 36-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenan...
    Medical condition: Heartburn and Erosive Esophagitis in Adolescent Subjects
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10018203 GERD LLT
    14.1 10017947 - Gastrointestinal disorders 10019326 Heartburn LLT
    14.1 10017947 - Gastrointestinal disorders 10063657 Erosive esophagitis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) PT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000187-42 Sponsor Protocol Number: 156-12-298 Start Date*: 2016-10-24
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan followed by a Two Year Open-l...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004868-11 Sponsor Protocol Number: HZA113714 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline Research & Development
    Full Title: A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily compa...
    Medical condition: Asthma
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001582-27 Sponsor Protocol Number: 156-13-207 Start Date*: Information not available in EudraCT
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Pilot Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Efficacy, and Pharmacokinetics of Titrated Oral SAMSCA® (Tolvaptan) in Children and Adolescent Subje...
    Medical condition: Euvolemic or Hypervolemic Hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10021038 Hyponatremia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002810-11 Sponsor Protocol Number: 156-11-294 Start Date*: 2015-03-26
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Have Previously Participated ...
    Medical condition: Euvolemic or Hypervolemic Hyponatremia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10021038 Hyponatremia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended) CZ (Prematurely Ended) RO (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002379-40 Sponsor Protocol Number: CAFQ056B2278 Start Date*: 2012-01-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome
    Medical condition: Fragile X syndrome
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10017324 Fragile X syndrome PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DE (Prematurely Ended) Outside EU/EEA GB (Prematurely Ended) ES (Temporarily Halted) DK (Prematurely Ended) IT (Completed) FR (Completed) NL (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
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    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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