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Clinical trials for GAIN domain

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    20 result(s) found for: GAIN domain. Displaying page 1 of 1.
    EudraCT Number: 2020-003012-27 Sponsor Protocol Number: 18062020 Start Date*: 2021-01-12
    Sponsor Name:Canisius Wilhelmina Ziekenhuis
    Full Title: Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy
    Medical condition: Late-onset hypogonadism
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003466-12 Sponsor Protocol Number: MCMK0220 Start Date*: 2022-03-25
    Sponsor Name:MCM Klosterfrau Vertriebsgesellschaft mbH
    Full Title: A double-blind, randomised, multi-centre, controlled clinical trial to compare D-mannose versus antibiotic in the treatment of acute uncomplicated lower urinary tract infections in female patients
    Medical condition: acute uncomplicated lower urinary tract infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10024981 Lower urinary tract infection LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004917-10 Sponsor Protocol Number: TIGER Start Date*: 2023-06-29
    Sponsor Name:King's College London [...]
    1. King's College London
    2. King's College Hospital NHS Foundation Trust
    Full Title: Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative age-Related macular degeneration (TIGER): a phase 3, pan-European, two-gro...
    Medical condition: Submacular haemorrhage secondary to exudative age-related macular degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10075718 Exudative age-related macular degeneration LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-003339-74 Sponsor Protocol Number: Start Date*: 2011-09-23
    Sponsor Name:Moorfields Eye Hospital R&D Department
    Full Title: A Prospective Randomised Controlled Trial of Intravitreal Ozurdex and Macular Laser Therapy versus Macular Laser Therapy only in Diabetic Macular Oedema (OZLASE study)
    Medical condition: Diabetic macular oedema
    Disease: Version SOC Term Classification Code Term Level
    14.0 10015919 - Eye disorders 10025415 Macular oedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-003193-17 Sponsor Protocol Number: BAY86-5321/17514 Start Date*: 2016-08-30
    Sponsor Name:Bayer AG
    Full Title: A multi center, single arm, interventional Phase 4 study to evaluate a Treat and Extend regimen of intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion
    Medical condition: Macular edema secondary to CRVO
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10025415 Macular oedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) DK (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-004740-24 Sponsor Protocol Number: INCB54828-209 Start Date*: 2022-06-29
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System ...
    Medical condition: Participants at least 18 years of age who have recurrent GBM or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors, harboring an FGFR1-3 mutation or fus...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) DK (Completed) FR (Completed) IT (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000370-10 Sponsor Protocol Number: POLEMCCR4673 Start Date*: 2018-05-09
    Sponsor Name:The Royal Marsden NHS Foundation Trust
    Full Title: Avelumab plus fluoropyrimidine-based chemotherapy as adjuvant treatment for stage III dMMR or POLE exonuclease domain mutant colon cancer: A phase III randomised study.
    Medical condition: Colon cancer stage III
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10009949 Colon cancer Duke's C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-004530-11 Sponsor Protocol Number: ALT-L9-03 Start Date*: 2022-04-21
    Sponsor Name:Altos Biologics Inc.
    Full Title: A Randomized, Phase 3, Double Masked, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of ALT L9 Versus Eylea® in Patients With Neovascular Age Related Macular Degeneration (ALT...
    Medical condition: Neovascular Age Related Macular Degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10075568 Wet age-related macular degeneration LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) SK (Completed) LV (Completed) AT (Completed) ES (Ongoing) BG (Completed) EE (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002100-25 Sponsor Protocol Number: THR-317-001 Start Date*: 2016-11-22
    Sponsor Name:ThromboGenics NV
    Full Title: A Phase 2, single-masked, multicentre study to evaluate the safety and efficacy of 2 dose levels of THR-317 for the treatment of diabetic macular oedema (DME)
    Medical condition: diabetic macular oedema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000015084 10057915 Diabetic macular oedema LLT
    20.0 100000015084 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2018-003298-90 Sponsor Protocol Number: OPT-302-1003 Start Date*: 2018-12-07
    Sponsor Name:Opthea Ltd
    Full Title: Phase 1b/2a study of OPT-302 in combination with aflibercept for persistent central-involved diabetic macular edema
    Medical condition: Persistent central-involved diabetic macular edema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10015919 Eye disorders SOC
    20.1 10015919 - Eye disorders 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed)
    Trial results: View results
    EudraCT Number: 2021-000590-93 Sponsor Protocol Number: CR213-20 Start Date*: 2023-06-09
    Sponsor Name:CuraTeQ Biologics Private Ltd.
    Full Title: A Phase 3, Randomized, Double-Blind, Parallel Group, Multicenter Study to Compare Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BP05 Versus EU-Approved Lucentis® in Patients with Wet (N...
    Medical condition: Wet (Neovascular) Age-Related Macular Degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10075568 Wet age-related macular degeneration LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Trial now transitioned) LV (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-003661-17 Sponsor Protocol Number: SS01 Start Date*: 2012-11-09
    Sponsor Name:Moorfields Eye Hospital NHS Foundation Trust
    Full Title: A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed versus PRN dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in patie...
    Medical condition: Diabetic macular oedema
    Disease: Version SOC Term Classification Code Term Level
    14.1 10015919 - Eye disorders 10057915 Diabetic macular oedema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-002930-19 Sponsor Protocol Number: XBR1001 Start Date*: 2019-02-25
    Sponsor Name:Xbrane Biopharma
    Full Title: A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane versus Lucentis® in Patients with Neovascular Age-Related Macular Degeneration
    Medical condition: Wet Age-related macular degeneration (AMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10071129 Neovascular age-related macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LT (Completed) HU (Completed) SK (Completed) LV (Completed) CZ (Completed) BG (Completed) PL (Completed) ES (Ongoing) RO (Completed)
    Trial results: View results
    EudraCT Number: 2021-005173-95 Sponsor Protocol Number: DX219 Start Date*: 2022-09-01
    Sponsor Name:Oculis SA
    Full Title: A Phase 2/3 Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
    Medical condition: Diabetic Macular Edema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) ES (Ongoing)
    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: 2016-004479-35 Sponsor Protocol Number: VX16-661-115 Start Date*: Information not available in EudraCT
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed) DK (Completed) BE (Completed) DE (Completed) GB (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-004300-34 Sponsor Protocol Number: MLN0002-3024 Start Date*: 2021-06-25
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative C...
    Medical condition: Moderately to severely active Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) CZ (Prematurely Ended) SK (Prematurely Ended) HU (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned) ES (Prematurely Ended) HR (Trial now transitioned) BE (Trial now transitioned) Outside EU/EEA PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000547-27 Sponsor Protocol Number: CTIMPMCRENAL12 Start Date*: 2012-11-01
    Sponsor Name:East and North Hertfordshire NHS Trust [...]
    1. East and North Hertfordshire NHS Trust
    2. University of Hertfordshire
    Full Title: A Pilot Randomised Controlled Trial of Drug Treatment for Depression in Patients undergoing Haemodialysis
    Medical condition: Major Depressive Disorder in Patients with End Stage Renal Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10025453 Major depressive disorder NOS LLT
    14.1 10042613 - Surgical and medical procedures 10066623 Chronic haemodialysis LLT
    14.1 10038359 - Renal and urinary disorders 10014647 End stage renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-004893-25 Sponsor Protocol Number: CRO2035 Start Date*: 2014-07-08
    Sponsor Name:Imperial College London
    Full Title: RITUXILUP - An open label randomised multicentre controlled trial of RITUXImab and mycophenolate mofetil (MMF) without oral steroids for the treatment of LUPus nephritis
    Medical condition: Lupus nephritis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004301-31 Sponsor Protocol Number: MLN0002-3025 Start Date*: 2021-06-25
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Dise...
    Medical condition: Moderately to severely active Crohn’s disease (CD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10058815 Crohn's disease acute episode LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) CZ (Prematurely Ended) SK (Prematurely Ended) HU (Trial now transitioned) IT (Trial now transitioned) ES (Prematurely Ended) HR (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) Outside EU/EEA
    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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