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Clinical trials for Language delay

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 ).  
     
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    20 result(s) found for: Language delay. Displaying page 1 of 1.
    EudraCT Number: 2016-000222-19 Sponsor Protocol Number: H2020-PHC-18-2015-667224 Start Date*: 2017-08-02
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome – a blinded randomized placebo-controlled parallel group multicenter trial for superiori...
    Medical condition: Perinatal Asphyxia, hypoxic-ischemic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    20.0 10029205 - Nervous system disorders 10014633 Encephalopathy neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) NO (Trial now transitioned) ES (Ongoing) FI (Trial now transitioned) EE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) PT (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001466-42 Sponsor Protocol Number: 17-HPNCL-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Fondation Lenval - Hôpitaux Pédiatriques de Nice CHULENVAL
    Full Title: EFFECTIVENESS OF INTRANASAL DEXMEDETOMIDINE FOR SEDATED AUDITORY BRAINSTEM RESPONSE TESTING
    Medical condition: Child requiring auditory evaluation in a context of suspicion of deafness, language delay, overall developmental delay, risk factors for hearing loss.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10049507 Brain stem auditory evoked response PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003972-64 Sponsor Protocol Number: 2015-09 Start Date*: 2019-07-02
    Sponsor Name:ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    Full Title: Plasma and tissue pharmacokinetics of amikacin administrated by dressing impregnated in burns patients
    Medical condition: burns patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004057-23 Sponsor Protocol Number: 2021-12945 Start Date*: 2022-02-28
    Sponsor Name:Radboudumc
    Full Title: Ethanol submandibular duct ligation for drooling in children with neurodisabilities
    Medical condition: Drooling or sialorrhea
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003400-39 Sponsor Protocol Number: NGLU-CL02 Start Date*: 2014-07-15
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase I/II Open Label Study in MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
    Medical condition: Mucopolysaccharidosis III, type B (MPS IIIB), Sanfilippo B
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    19.0 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) ES (Temporarily Halted)
    Trial results: View results
    EudraCT Number: 2015-000891-85 Sponsor Protocol Number: 190-203 Start Date*: 2017-09-05
    Sponsor Name:BioMarin Pharmaceutical Inc
    Full Title: A Phase 2, Open-Label, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Intracerebroventricular BMN 190 in Pediatric Patients < 18 years of age with CLN2 Disease
    Medical condition: Neuronal Ceroid Lipofuscinosis type 2 (CLN2) disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10052074 Neuronal ceroid lipofuscinosis NOS LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002574-31 Sponsor Protocol Number: US1/001/10(TDU13600) Start Date*: 2013-10-25
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A Phase I/IIa Dose Escalation Safety Study of Subretinally Injected SAR421869, Administered to Patients with Retinitis Pigmentosa Associated with Usher Syndrome Type 1B
    Medical condition: Retinitis Pigmentosa, associated with Ushers Syndrome Type 1B.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    20.0 10010331 - Congenital, familial and genetic disorders 10063396 Usher's syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-000659-42 Sponsor Protocol Number: TN-22 Start Date*: 2019-03-12
    Sponsor Name:TrialNet Coordinating Center
    Full Title: HYDROXYCHLOROQUINE FOR PREVENTION OF ABNORMAL GLUCOSE TOLERANCE AND DIABETES IN INDIVIDUALS AT-RISK FOR TYPE 1 DIABETES MELLITUS
    Medical condition: individuals at-risk for type 1 diabetes mellitus (T1D)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (GB - no longer in EU/EEA) IT (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2020-001109-22 Sponsor Protocol Number: PBGM01-001 Start Date*: Information not available in EudraCT
    Sponsor Name:Passage Bio, Inc.
    Full Title: A Phase 1/2 Open-Label, Multicenter, Dose Ranging and Confirmatory Study to Assess the Safety, Tolerability and Efficacy of a Single Dose of PBGM01 Delivered into the Cisterna Magna of Pediatric Su...
    Medical condition: GM1 gangliosidosis (GM1) is an autosomal recessive disorder that results from mutations in the human galactosidase beta 1 gene (GLB1), which encodes beta-galactosidase (β-gal).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-002548-26 Sponsor Protocol Number: 0139 Start Date*: 2020-12-16
    Sponsor Name:Royal College of Surgeons in Irlenad
    Full Title: Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomised, placebo controlled trial
    Medical condition: Late onset sepsis & necrotising enterocolitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    20.1 100000004856 10028884 Necrotising enterocolitis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-000105-53 Sponsor Protocol Number: 17P-FU-004 Start Date*: 2011-04-20
    Sponsor Name:Hologic, Inc.
    Full Title: Estudio prospectivo, de seguimiento, de niños de 23 a 25 meses, nacidos de madres que recibieron Caproato de Hidroxiprogesterona inyectable, 250 mg/ml o vehículo, para la prevención del parto prema...
    Medical condition: Este es un estudio prospectivo, de seguimiento, diseñado para aportar una evaluación del desarrollo de niños nacidos de madres que participaron en el ensayo de eficacia de 17P
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004016-11 Sponsor Protocol Number: 2305 Start Date*: 2016-06-30
    Sponsor Name:University of Bristol
    Full Title: What is the clinical and cost effectiveness of benzocaine/phenazone ear drops for reducing antibiotic consumption and ear pain in children aged between 6 months and 10 years presenting to primary c...
    Medical condition: Acute otitis media
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10014020 Ear pain PT
    20.1 10013993 - Ear and labyrinth disorders 10065838 Middle ear inflammation PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-001530-10 Sponsor Protocol Number: NoPac01 Start Date*: 2017-02-20
    Sponsor Name:Royal Devon & Exeter NHS Foundation Trust
    Full Title: A randomised controlled trial of topical intranasal tranexamic acid versus placebo to reduce the need for nasal packing in patients presenting to the Emergency Department with spontaneous epistaxis.
    Medical condition: Atraumatic epistaxis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10015090 Epistaxis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-004411-11 Sponsor Protocol Number: NeoTreme Start Date*: 2023-05-03
    Sponsor Name: University Hospital Schleswig-Holstein, Campus Lübeck
    Full Title: Phase 2 Study of Preoperative Gemcitabine Plus Cisplatin with Durvalumab (MEDI4736) and Tremelimumab in intrahepatic cholangiocarcinoma (NeoTreme)
    Medical condition: Intrahepatic cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-006295-37 Sponsor Protocol Number: 06/AN/04 Start Date*: 2007-04-05
    Sponsor Name:NHS Greater Glasgow & Clyde
    Full Title: A multi-site RCT comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants.
    Medical condition: Inguinal hernia in neonates and infants
    Disease: Version SOC Term Classification Code Term Level
    8.1 10022016 Inguinal hernia PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000453-41 Sponsor Protocol Number: BMBF-Fz01KG1602 Start Date*: 2018-05-29
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety...
    Medical condition: Extremely low gestational age neonates (ELGANs), i.e. those who are born at <28 weeks gestation and who uniformly suffer from intermittent hypoxemic episodes.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    20.1 10017947 - Gastrointestinal disorders 10055667 Necrotising enterocolitis neonatal PT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071101 Primary apnoea of premature newborns LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-013616-12 Sponsor Protocol Number: R096769PRE3008 Start Date*: 2010-04-12
    Sponsor Name:Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dy...
    Medical condition: Premature ejaculation
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036596 Premature ejaculation LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-004909-27 Sponsor Protocol Number: DNLI-E-0002 Start Date*: 2020-07-22
    Sponsor Name:Denali Therapeutics Inc.
    Full Title: A PHASE 1/2, MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF DNL310 IN PEDIATRIC SUBJECTS WITH HUNTER SYNDROME
    Medical condition: Hunter Syndrome (Mucopolysaccharidosis Type II [MPS II])
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10056917 Hunter's syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000287-42 Sponsor Protocol Number: I15015 Start Date*: 2016-05-18
    Sponsor Name:CHU de Limoges
    Full Title: A Multicentre Open label Phase II study of Daratumumab in AL Amyloidosis Patients not in VGPR or Better
    Medical condition: AL Amyloidosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10005329 - Blood and lymphatic system disorders 10035227 Plasma cell neoplasms HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000567-26 Sponsor Protocol Number: 2010-021883-14 Start Date*: 2013-01-31
    Sponsor Name:Radboud University Medical Centre Nijmegen
    Full Title: A randomized double-blind, placebo-controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents.
    Medical condition: Conduct Disorder DSM-IV-TR; 312.8x¸ APA, 2000
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10064478 Conduct disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) DE (Ongoing) GB (GB - no longer in EU/EEA) ES (Ongoing) FR (Ongoing)
    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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