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Clinical trials for Developmental 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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    37 result(s) found for: Developmental delay. Displaying page 1 of 2.
    1  2  Next»
    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: 2021-004393-62 Sponsor Protocol Number: NBI-921352-DEE2013 Start Date*: 2022-03-18
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: A Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encep...
    Medical condition: SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8ADEE)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10077380 Epileptic encephalopathy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DK (Prematurely Ended) NL (Prematurely Ended) BE (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) FR (Ongoing) IT (Prematurely Ended) DE (Prematurely Ended) PT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-004025-28 Sponsor Protocol Number: HTA 05-14-02 Start Date*: 2007-06-26
    Sponsor Name:Royal Liverpool Children’s NHS Trust
    Full Title: MENDS: The use of MElatonin in children with Neuro-developmental Disorders and impaired Sleep; a randomised, double-blind, placebo-controlled, parallel study
    Medical condition: children with neuro-developmental disorders and impaired sleep
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064062 Neurodevelopmental disorder PT
    9.1 10040984 Sleep disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2020-003140-83 Sponsor Protocol Number: NBI-921352-DEE2012 Start Date*: 2021-10-12
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developm...
    Medical condition: SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10077380 Epileptic encephalopathy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) DK (Completed) PL (Completed) DE (Completed) BE (Completed) FR (Completed) NL (Completed) ES (Completed) IT (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002821-32 Sponsor Protocol Number: FENDEEP Start Date*: 2021-12-09
    Sponsor Name:Neurologia Aplicada, SLP
    Full Title: The FENDEEP Study: Fenfluramine for the treatment of different types of developmental and epileptic encephalopathies: a pilot trial exploring epileptic and non-epileptic outcomes.
    Medical condition: Five different types of developmental and epileptic encephalopathies (DEEs): SYNGAP1 and STXBP1 encephalopathies, inv-dup(15) encephalopathy, multifocal or bilateral Malformations of Cortical Devel...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10053551 Intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    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: 2020-001055-40 Sponsor Protocol Number: 111-209 Start Date*: 2020-07-29
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A randomized, controlled, open-label clinical trial with an open-label extension to investigate the safety of BMN 111 in infants and young children with achondroplasia at risk of requiring cervicom...
    Medical condition: achondroplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-002051-42 Sponsor Protocol Number: R119861 Start Date*: 2019-10-25
    Sponsor Name:University of Manchester
    Full Title: A phase I-II, study of autologous CD34+ haematopoietic stem cells transduced ex vivo with CD11b lentiviral vector encoding for human SGSH in patients with mucopolysaccharidosis type IIIA (MPS IIIA,...
    Medical condition: MPS IIIA, mucopolysaccharidosis type IIIA
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10028093 Mucopolysaccharidosis PT
    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: 2020-005908-18 Sponsor Protocol Number: 1111_1111 Start Date*: 2021-11-03
    Sponsor Name:AOU FEDERICO II
    Full Title: Functional-genetic stratification as a guide to personalized treatment in developmental and epileptic encephalopathies due to potassium channel mutations
    Medical condition: Epileptic Encephalopathy with developmental delay
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10015039 Epilepsy congenital PT
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (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: 2016-002408-13 Sponsor Protocol Number: NL58183.041.16 Start Date*: 2017-02-07
    Sponsor Name:UMC Utrecht
    Full Title: Bumetanide to Ameliorate Tuberous Sclerosis Complex Hyperexcitable Behaviors
    Medical condition: Tuberous Sclerosis Complex
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003031-35 Sponsor Protocol Number: R04049 Start Date*: 2015-11-20
    Sponsor Name:Central Manchester University Hospitals NHS Foundation Trust
    Full Title: A Single Centre Study Investigating the Safety and Efficacy of an Immune Modulation Regimen in Mitigating the Alloimmune Response to Intravenous Laronidase in Infants With Severe Mucopolysaccharido...
    Medical condition: Severe Mucopolysaccharidosis Type I (Hurler syndrome, MPS IH)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10028094 Mucopolysaccharidosis IH LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-019519-39 Sponsor Protocol Number: RAPIT Start Date*: 2012-03-14
    Sponsor Name:Erasmus MC - Department of Neurology
    Full Title: Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial)
    Medical condition: Tuberous Sclerosis Complex
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021576-28 Sponsor Protocol Number: DFG Fr 1455/6-1 Start Date*: 2011-06-21
    Sponsor Name:Universitätsklinikum Tuebingen
    Full Title: Effects of transfusion thresholds on neurocognitive outcome of extremely low birth weight infants (ETTNO) a blinded randomized controlled multicenter trial
    Medical condition: extreme prematurity anemia of prematurity neurodevelopmental impairment
    Disease: Version SOC Term Classification Code Term Level
    12.1 10002307 Anemia of prematurity LLT
    12.1 10036615 Prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003960-20 Sponsor Protocol Number: SHP-610-201 Start Date*: 2015-02-18
    Sponsor Name:Shire human Genetic Therapies, Inc.
    Full Title: A Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration via an Intrathecal Drug Delivery Device in...
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    17.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Prematurely Ended) NL (Completed) GB (Prematurely Ended) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    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: 2018-002484-25 Sponsor Protocol Number: TAK-935-2002(OV935) Start Date*: 2019-04-29
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAK-935 (OV935) AS AN ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS WITH ...
    Medical condition: Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-000599-40 Sponsor Protocol Number: KH176-202 Start Date*: 2019-10-23
    Sponsor Name:Khondrion B.V.
    Full Title: A Phase IIb double-blind, randomised, placebo-controlled, multi-centre, confirmative three-way cross-over study on cognitive function with two doses of KH176 in subjects with a genetically confirme...
    Medical condition: A genetically confirmed mitochondrial desoxyribonucleic acid (DNA) transfer ribonucleic acid (tRNA)Leu(UUR) m.3243A>G mutation (including but not limited to MELAS, MIDD and mixed compositions).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002080-26 Sponsor Protocol Number: V58P15 Start Date*: 2013-08-28
    Sponsor Name:Novartis Vaccines & Diagnostics AG
    Full Title: A Phase III, Observer-Blind, Randomized Multicenter Study to Evaluate the Safety of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture (tivc) or in Embryonated Eggs (TI...
    Medical condition: volunteers at high risk for influenza-related complications (protection against influenza)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10016794 Flu vaccination LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed)
    Trial results: View results
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