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Clinical trials for System justification

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   44294   clinical trials with a EudraCT protocol, of which   7351   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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    18 result(s) found for: System justification. Displaying page 1 of 1.
    EudraCT Number: 2020-004084-10 Sponsor Protocol Number: T001018N Start Date*: 2022-05-16
    Sponsor Name:Flemisch Fund for Scientific Research - Fonds voor Wetenschappelijk Onderzoek
    Full Title: Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment; a pragmatic randomised controlled trial
    Medical condition: Rifampicin resistant (RR-TB) and drug resistant (DR-TB) tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10049031 Genotype drug resistance test PT
    20.1 10018065 - General disorders and administration site conditions 10048723 Multiple-drug resistance PT
    20.0 10018065 - General disorders and administration site conditions 10059866 Drug resistance PT
    20.0 100000004862 10004052 Bacterial resistance LLT
    20.0 100000004862 10038637 Resistance bacterial LLT
    20.1 100000004862 10028152 Multi-antibiotic resistance LLT
    20.0 10022891 - Investigations 10070974 Antibiotic resistance test LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2008-006444-19 Sponsor Protocol Number: AX200-101 Start Date*: 2009-05-12
    Sponsor Name:SYGNIS Bioscience GmbH & Co. KG
    Full Title: AXIS 2: AX200 for the treatment of ischemic stroke A multinational, multicenter, randomized, doubleblind, placebo-controlled, phase II trial
    Medical condition: ischemic stroke
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061256 Ischaemic stroke LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) AT (Completed) CZ (Completed) ES (Completed) SE (Prematurely Ended) PL (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004898-41 Sponsor Protocol Number: NBK241/1/2020 Start Date*: 2021-03-31
    Sponsor Name:MEDICAL UNIVERSITY OF GDAŃSK
    Full Title: A multicentre, parallel group, randomised, double blind, placebo-controlled, phase II study evaluating the efficacy and safety of reperfusion thrombolytic therapy with intravenous recombinant tissu...
    Medical condition: Acute ischemic stroke
    Disease: Version SOC Term Classification Code Term Level
    22.1 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001240-61 Sponsor Protocol Number: allo-APZ2-ACLF-II-01 Start Date*: 2018-12-19
    Sponsor Name:RHEACELL GmbH & Co. KG
    Full Title: An interventional, single arm, multicenter, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-ACLF for the treatment of acute-on-chronic liver failure (ACLF)
    Medical condition: Acute-on-Chronic Liver Failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10077305 Acute on chronic liver failure PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005504-18 Sponsor Protocol Number: APHP201185 Start Date*: 2021-05-21
    Sponsor Name:Assistance Publique – Hôpitaux de Paris (AP-HP)
    Full Title: Lenvatinib in neo-adjuvant and adjuvant therapy for poor-prognosis BCLC A HepatoCellular Carcinoma treated by ablative procedure in a curative intent: multicentre phase 2 therapeutic trial
    Medical condition: NA
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001807-19 Sponsor Protocol Number: TV50717-CNS-30081 Start Date*: 2019-11-12
    Sponsor Name:Teva Branded Pharmaceutical Products R&D, Inc.
    Full Title: An Open-Label, Long-Term Safety, Tolerability, and Efficacy Study of TEV-50717 (Deutetrabenazine) for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Open RECLAIM-DCP)
    Medical condition: Dyskinesia in cerebral palsy (DCP)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10068804 Athetoid cerebral palsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Prematurely Ended) DK (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-005611-31 Sponsor Protocol Number: CORT113176-652 Start Date*: 2022-09-07
    Sponsor Name:Corcept Therapeutics Incorporated
    Full Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients with Amyotrophic Lateral Sclerosis (DAZALS)
    Medical condition: Amyotrophic Lateral Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10002026 Amyotrophic lateral sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004460-19 Sponsor Protocol Number: P1604GTN Start Date*: 2017-04-20
    Sponsor Name:G. Pohl-Boskamp GmbH & Co.KG
    Full Title: A multi-centre, randomized, placebo-controlled, double-blind trial to assess the efficacy and safety of nitroglycerin sublingual powder on walking distance in a scheduled forced titration design in...
    Medical condition: Peripheral arterial occlusive disease (PAOD, femoro-popliteal stenosis) and intermittent claudication (Fontaine stage IIb, pain-free walking distance < 200 m), lasting for at least 3 months to ensu...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10074576 Peripheral arterial occlusive disease Fontaine stage IIb LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000709-10 Sponsor Protocol Number: UKM12_0026 Start Date*: 2014-12-19
    Sponsor Name:Universitätsklinikum Münster
    Full Title: Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential
    Medical condition: relapsing-remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002320-33 Sponsor Protocol Number: GRC17536-203 Start Date*: 2012-09-27
    Sponsor Name:Glenmark Pharmaceuticals SA
    Full Title: A Phase 2, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Pe...
    Medical condition: Pain associated with diabetic peripheral neuropathy (DPN).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10012683 Diabetic peripheral neuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-001419-64 Sponsor Protocol Number: NOR-107 Start Date*: 2014-01-24
    Sponsor Name:Takeda Vaccines (Montana), Inc.
    Full Title: A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuv...
    Medical condition: Prevention of gastroenteritis caused by norovirus
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10068189 Gastroenteritis norovirus PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-001379-21 Sponsor Protocol Number: VX15-770-126 Start Date*: 2017-08-01
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Init...
    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: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000931-35 Sponsor Protocol Number: D6470C00005 Start Date*: 2020-10-05
    Sponsor Name:AstraZeneca AB, 151 85 Södertälje, Sweden
    Full Title: A Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults with Type 2 Diabetes
    Medical condition: Type 2 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-000127-32 Sponsor Protocol Number: ROPETAR Start Date*: 2011-11-03
    Sponsor Name:Werkgroep Immunotherapie Nederland voor Oncologie
    Full Title: A randomized phase II study to explore the efficacy and feasibility of upfront bi-monthly rotations between Everolimus and Pazopanib with sequential treatment of first line Pazopanib and second lin...
    Medical condition: Advanced or metastatic clear cell renal cancer.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10038416 Renal clear cell carcinoma LLT
    16.1 100000004864 10009251 Clear cell carcinoma of the kidney LLT
    16.1 100000004864 10023400 Kidney cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-006441-10 Sponsor Protocol Number: 116-02 Start Date*: 2009-06-03
    Sponsor Name:SCIPHARM SáRL
    Full Title: A double blind controlled clinical study to investigate the efficacy and tolerability of subcutaneous Treprostinil sodium in patients with severe non-operable Chronic Thromboembolic Pulmonary Hyper...
    Medical condition: Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) SK (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005879-16 Sponsor Protocol Number: GRC17536-201 Start Date*: 2012-06-11
    Sponsor Name:Glenmark Pharmaceuticals SA
    Full Title: A Phase II, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic N...
    Medical condition: Pain associated with diabetic peripheral neuropathy (DPN).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10012683 Diabetic peripheral neuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-003697-10 Sponsor Protocol Number: 109MS302 Start Date*: 2007-04-13
    Sponsor Name:Biogen Idec Ltd.
    Full Title: A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple...
    Medical condition: Relapsing-Remitting Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10063399 Relapsing-remitting multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) ES (Completed) IE (Completed) GR (Completed) EE (Completed) LV (Completed) BG (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004805-30 Sponsor Protocol Number: CLN-PXT3003-06 Start Date*: Information not available in EudraCT
    Sponsor Name:Pharnext SCA
    Full Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A)
    Medical condition: Charcot Marie Tooth Type 1A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10008414 Charcot-Marie-Tooth disease LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) NL (Prematurely Ended) DK (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) FR (Prematurely Ended)
    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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