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Clinical trials for Legal issues

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   44412   clinical trials with a EudraCT protocol, of which   7421   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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    42 result(s) found for: Legal issues. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2009-017032-41 Sponsor Protocol Number: AI424-402 Start Date*: 2011-08-01
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: An Open-Label, Randomized Study Evaluating a Switch from a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors plus any Third Agent to either a Regimen of Atazanavir/Ritonavir Once Daily and...
    Medical condition: HIV-1 infected subjects who are virologically suppressed on a regimen of 2 NRTIs plus any 3rd agent, but experience safety and/or tolerability issues to this regimen.
    Disease: Version SOC Term Classification Code Term Level
    15.0 10021881 - Infections and infestations 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000327-27 Sponsor Protocol Number: ISIS396443-CS2 Start Date*: 2017-01-26
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: An Open-Label, Dose Escalation Study to Assess the Safety, Tolerability and Dose-Range Finding of Multiple Doses of ISIS 396443 Delivered Intrathecally to Patients With Spinal Muscular Atrophy
    Medical condition: Spinal Muscular Atrophy (SMA)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-004152-20 Sponsor Protocol Number: AVA 102675 Start Date*: 2007-11-16
    Sponsor Name:GlaxoSmithKline Research & Development
    Full Title: A 52-week open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-t...
    Medical condition: Mild-moderate Alzheimer disease
    Disease: Version SOC Term Classification Code Term Level
    6.1 10012271 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) SE (Prematurely Ended) BE (Completed) ES (Completed) GR (Prematurely Ended) FR (Completed) CZ (Prematurely Ended) AT (Prematurely Ended) DE (Prematurely Ended) GB (Prematurely Ended) FI (Prematurely Ended) SI (Prematurely Ended) HU (Prematurely Ended) NL (Prematurely Ended) PT (Prematurely Ended) SK (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-000381-36 Sponsor Protocol Number: 26083 Start Date*: 2006-04-26
    Sponsor Name:University of Nottingham
    Full Title: Randomised controlled trials to investigate whether prophylactic antibiotics can prevent further episodes of cellulitis (erysipelas) of the leg (PATCH I & PATCH II)
    Medical condition: Cellulitis of the leg
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000621-12 Sponsor Protocol Number: ISIS396443-CS3A Start Date*: 2017-02-15
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: A Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Patients With Infantile-Onset Spinal Muscular Atrophy
    Medical condition: Spinal Muscular Atrophy (SMA)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001366-14 Sponsor Protocol Number: 207757 Start Date*: 2017-09-14
    Sponsor Name:GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
    Full Title: A long-term safety and efficacy follow-on study in participants with transfusion dependent β-thalassemia who have previously received GSK2696277 (autologous hematopoietic stem cells genetically mod...
    Medical condition: Beta-thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-020154-33 Sponsor Protocol Number: RTG113388 Start Date*: 2012-03-09
    Sponsor Name:GlaxoSmithKline R&D Limited
    Full Title: RTG113388, a Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects with Partial Onset Seizures(≥12 years old) and Subjects with Lennox-Gastaut Syndrome (≥12 ...
    Medical condition: Uncontrolled partial onset seizures or Lennox Gastaut Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061334 Partial seizures PT
    14.1 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005003-41 Sponsor Protocol Number: 392MD/15/C Start Date*: Information not available in EudraCT
    Sponsor Name:Strakan Pharmaceuticals Ltd
    Full Title: A randomised, active control, double-blind, double-dummy, parallel-group, multi-national study to assess the efficacy, tolerability and safety of the granisetron transdermal delivery system (GTDS) ...
    Medical condition: Chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic multi-day chemotherapy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003130-27 Sponsor Protocol Number: 2015/2294 Start Date*: 2017-05-15
    Sponsor Name:Gustave Roussy
    Full Title: An international multicenter phase II randomized trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chem...
    Medical condition: Very High Risk neuroblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10008126 Cerebral neuroblastoma LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) IT (Prematurely Ended) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) NL (Completed) AT (Prematurely Ended) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003688-25 Sponsor Protocol Number: INS1007-301 Start Date*: 2021-04-08
    Sponsor Name:Insmed Incorporated
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibros...
    Medical condition: Non-Cystic Fibrosis Bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    23.0 10038738 - Respiratory, thoracic and mediastinal disorders 10083611 Non-cystic fibrosis bronchiectasis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Completed) DK (Completed) NL (Completed) IE (Completed) HU (Completed) GR (Completed) PL (Completed) BG (Completed) LT (Prematurely Ended) SK (Completed) AT (Completed) FR (Completed) EE (Prematurely Ended) BE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-021572-29 Sponsor Protocol Number: AMB114588 Start Date*: 2010-11-23
    Sponsor Name:GlaxoSmithKline Research & Development, Ltd
    Full Title: An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    12.1 10064911 Pulmonary arterial hypertension LLT
    12.1 10065150 Associated with pulmonary arterial hypertension LLT
    12.1 10065151 Idiopathic pulmonary arterial hypertension LLT
    12.1 10065152 Familial pulmonary arterial hypertension LLT
    12.1 10064911 Pulmonary arterial hypertension PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Prematurely Ended) DE (Completed) NL (Ongoing) ES (Completed) HU (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-001266-17 Sponsor Protocol Number: DMD114349 Start Date*: 2011-08-08
    Sponsor Name:GlaxoSmithKline Research and Development LTD
    Full Title: An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: BE (Prematurely Ended) FR (Ongoing) DE (Completed) GB (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) Outside EU/EEA BG (Prematurely Ended) HU (Prematurely Ended) DK (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005469-67 Sponsor Protocol Number: T&R.SKINP.02 Start Date*: 2009-01-20
    Sponsor Name:Thornton & Ross Limited
    Full Title: A multi-centre, double-blind, vehicle-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm, a topically applied sodium cromoglicate lotion, in the treatmen...
    Medical condition: Paediatric atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10003639 Atopic dermatitis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-000130-39 Sponsor Protocol Number: NEO014/FP/pMDI/paed Start Date*: 2007-02-08
    Sponsor Name:Neolab Ltd
    Full Title: A PHASE III, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED CROSSOVER STUDY TO COMPARE THE SYSTEMIC EFFECTS OF INHALED FLUTICASONE PROPIONATE HFA MDI 200g PER DAY VERSUS THE REFERENCE ...
    Medical condition: Mild asthma in pre-pubertal children.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002390-25 Sponsor Protocol Number: E21-04 Start Date*: 2022-01-20
    Sponsor Name:Fab'entech
    Full Title: A two-stage randomized, placebo-controlled, double-blind, phase 2a study to characterize the safety and pharmacokinetics of FBR-002 in patients hospitalized with COVID-19 need of supplemental oxyge...
    Medical condition: COVID-19 in hospitalized patients in need of supplemental oxygen and at risk of severe outcome
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000192-37 Sponsor Protocol Number: 2019_0007 Start Date*: 2021-10-04
    Sponsor Name:Hôpital Foch
    Full Title: Oxidative Phosphorylation Targeting In Malignant glioma Using Metformin plus radiotherapy temozolomide
    Medical condition: Patients with a diagnosis of Glioblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-001063-30 Sponsor Protocol Number: CI-PSI-5268-06-306 Start Date*: 2007-06-28
    Sponsor Name:Pharmasset, Inc.
    Full Title: A Multi-center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared with Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Pa...
    Medical condition: Chronic hepatitis due to hepatitis B virus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 Chronic hepatitis B LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) ES (Completed) GB (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-001061-14 Sponsor Protocol Number: CI-PSI-5268-06-305 Start Date*: 2007-06-28
    Sponsor Name:Pharmasset, Inc.
    Full Title: A Multi-center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared with Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Pa...
    Medical condition: Chronic hepatitis due to hepatitis B virus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 Chronic hepatitis B LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) ES (Completed) GB (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-004169-33 Sponsor Protocol Number: P04705 Start Date*: 2007-10-16
    Sponsor Name:Schering-Plough Research Institute, a division of Schering Corporation
    Full Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50 mcg BID Delivered by Dry Powder Inhaler (DISKUS®) Versus Mometasone Furoate/Formoterol Fumarate 200/1...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    8.1 10003553 Asthma LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) EE (Prematurely Ended) LT (Prematurely Ended) LV (Prematurely Ended) CZ (Prematurely Ended) DE (Prematurely Ended) SK (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000464-29 Sponsor Protocol Number: 0113-CL-2001 Start Date*: 2014-04-09
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving...
    Medical condition: CMV reactivation after Kidney Transplantation Receiving an Organ from a CMV-Seropositive Donor
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10049107 CMV viraemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    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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