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Clinical trials for Therapeutics

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    1,100 result(s) found for: Therapeutics. Displaying page 1 of 55.
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    EudraCT Number: 2016-001764-11 Sponsor Protocol Number: PTC124-GD-030-DMD Start Date*: 2020-01-21
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: A Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Ataluren (PTC124®) in Patients Aged ≥2 to <5 Years Old With Nonsense Mutation Dystrophinopathy
    Medical condition: nonsense mutation dystrophinopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    20.0 10010331 - Congenital, familial and genetic disorders 10059117 Becker's muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001767-67 Sponsor Protocol Number: PTC124-GD-045-DMD Start Date*: 2020-01-30
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: Phase 2 Clinical Pharmacology Study to Assess Dystrophin Levels in Subjects With nmDMD Before and After Treatment with Ataluren
    Medical condition: Non-Sense Mutation Duchenne Muscular Dystrophy (nmDMD)
    Disease:
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001691-11 Sponsor Protocol Number: PTC124-GD-046-DMD Start Date*: 2020-03-06
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: Phase 2, Non-Interventional, Clinical Study to Assess Dystrophin Levels in Subjects With Nonsense Mutation Duchenne Muscular Dystrophy Who Have Been Treated With Ataluren for ≥9 Months
    Medical condition: Non-Sense Mutation Duchenne Muscular Dystrophy (nmDMD)
    Disease:
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004740-36 Sponsor Protocol Number: PTCEMF-GD-004 Start Date*: 2019-10-14
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: A MULTICENTER RANDOMIZED PLACEBO-CONTROLLED PHASE 3 STUDY ON THE SAFETY AND EFFICACY OF DEFLAZACORT (EMFLAZA®) IN SUBJECTS WITH LIMB-GIRDLE MUSCULAR DYSTROPHY 2I (LGMD2I
    Medical condition: Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10028356 Muscular dystrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-004777-40 Sponsor Protocol Number: ColoAd1-9001 Start Date*: 2017-06-12
    Sponsor Name:PsiOxus Therapeutics Ltd
    Full Title: A multicentre observational study for the long term follow up of subjects that have been treated with enadenotucirev during interventional clinical trial
    Medical condition: Cancer; including Breast, Ovarian, Colorectal, Metastatic colorectal (those investigated as part of previous trials using Enadenotucirev).
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002533-42 Sponsor Protocol Number: ARC002 Start Date*: 2021-12-07
    Sponsor Name:Aimmune Therapeutics, Inc.
    Full Title: Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study
    Medical condition: Peanut Allergy
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-002087-47 Sponsor Protocol Number: ARC001 Start Date*: 2021-12-07
    Sponsor Name:Aimmune Therapeutics, Inc.
    Full Title: Oral Desensitization to Peanut in Peanut-Allergic Children and Adults using Characterized Peanut Allergen (CPNA) Oral Immunotherapy (OIT)
    Medical condition: Peanut Allergy
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001731-39 Sponsor Protocol Number: STRIM002-(205813) Start Date*: 2017-10-12
    Sponsor Name:Orchard Therapeutics (Europe) Ltd
    Full Title: Methodology study to investigate the utility of retroviral insertion site analysis in samples from subjects treated with Strimvelis™ gene therapy
    Medical condition: Adenosine deaminase (ADA) deficiency severe combined immunodeficiency
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10066367 Adenosine deaminase deficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000980-21 Sponsor Protocol Number: PTC124-GD-048-DMD Start Date*: 2021-06-24
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: An Open-Label Study Evaluating the Safety and Pharmacokinetics of Ataluren in Children From ≥6 Months to <2 Years of Age with Nonsense Mutation Duchenne Muscular Dystrophy
    Medical condition: Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-001297-63 Sponsor Protocol Number: MLORI201 Start Date*: 2023-04-13
    Sponsor Name:Melinta Therapeutics, LLC
    Full Title: A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose IV Oritavancin Versus Standard of Care for the Treatment of Pediatric Subjects...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BG (Trial now transitioned) LT (Trial now transitioned) LV (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) RO (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-004110-23 Sponsor Protocol Number: GTi1201-OLE Start Date*: 2016-03-29
    Sponsor Name:Grifols Therapeutics LLC
    Full Title: An Open-Label, Multicenter Study to Evaluate the Long-term Safety of Weekly Intravenous Alphal-Proteinase Inhibitor (Human), Modified Process 60 mg/kg in Subjects With Pulmonary Emphysema Due to Al...
    Medical condition: Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10014563 Emphysema pulmonary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) EE (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000532-22 Sponsor Protocol Number: PT001102 Start Date*: 2020-02-28
    Sponsor Name:Pearl Therapeutics Inc. [...]
    1. Pearl Therapeutics Inc.
    2. Pearl Therapeutics Inc.
    3. Pearl Therapeutics Inc.
    Full Title: A Randomized, Double-Blind, Parallel Group, Multi-Center 24 Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persis...
    Medical condition: Subjects With Persistent Asthma
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003248-12 Sponsor Protocol Number: HPN-100-012SO Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment with HPN-100, in Pediatric Subjects under 6 Years of Age with Urea Cycle Di...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003247-36 Sponsor Protocol Number: HPN-100-005SE Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN 100 Compared to Sodium Phenylbutyrate in Children 6–17 Years of Age with Urea Cycle Disorders, with a ...
    Medical condition: Urea Cycle Disorders
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003249-82 Sponsor Protocol Number: HPN-100-012SE Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment with HPN-100, in Pediatric Subjects under 6 Years of Age with Urea Cycle Di...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004228-70 Sponsor Protocol Number: IBP-9414-010 Start Date*: 2015-12-28
    Sponsor Name:Infant Bacterial Therapeutics AB
    Full Title: A randomized, double blind, parallel-group, dose escalation placebo-controlled multicentre study to investigate the safety and tolerability of IBP-9414 administered in preterm infants
    Medical condition: Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003898-26 Sponsor Protocol Number: 516-007 Start Date*: 2019-12-23
    Sponsor Name:Mirati Therapeutics, Inc.
    Full Title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO ASSESS THE MASS BALANCE, ROUTE OF ELIMINATION, AND METABOLIC PROFILE OF [14C] LABELED MGCD516 MALATE SALT IN HEALTHY MALE SUBJECTS
    Medical condition: Cancer/oncology
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10007050 Cancer LLT
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2022-003265-38 Sponsor Protocol Number: PTC743-NEU-005-FA Start Date*: 2022-10-22
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: An Open-Label Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Vatiquinone in Children With Friedreich Ataxia Younger Than 7 Years of Age
    Medical condition: Friedreich Ataxia
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2020-004803-15 Sponsor Protocol Number: 5051-102 Start Date*: 2023-09-18
    Sponsor Name:Sarepta Therapeutics, Inc.
    Full Title: An Open-Label Extension Study for Patients with Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10052655 Duchenne muscular dystrophy gene carrier PT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003929-34 Sponsor Protocol Number: AUT042063 Start Date*: 2016-03-10
    Sponsor Name:Autifony Therapeutics Limited
    Full Title: A Pilot Double-blind, Placebo-controlled Crossover Study to Explore the Possible Benefit of AUT00063, an Oral Modulator of Voltage-gated Potassium Channels, in Adult Post-lingual Unilateral Cochlea...
    Medical condition: Impaired speech understanding in users of cochlear implants
    Disease: Version SOC Term Classification Code Term Level
    19.0 10013993 - Ear and labyrinth disorders 10048812 Deafness unilateral PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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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