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Clinical trials for Specific developmental disorder

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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    19 result(s) found for: Specific developmental disorder. Displaying page 1 of 1.
    EudraCT Number: 2012-001630-33 Sponsor Protocol Number: MEM-MD-69 Start Date*: 2012-11-14
    Sponsor Name:Forest Research Institute, Inc
    Full Title: An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients with Autism, Asperger’s Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Medical condition: Autism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10003484 Asperger's disorder PT
    14.1 10029205 - Nervous system disorders 10008520 Childhood autism LLT
    14.1 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) BE (Completed) ES (Completed) NL (Ongoing) EE (Completed) FR (Ongoing) IS (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001568-31 Sponsor Protocol Number: MEM-MD-68 Start Date*: 2012-11-14
    Sponsor Name:Forest Research Institute, Inc
    Full Title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism, Asperger’s Disorder, or Pervasive Developmental Disorder ...
    Medical condition: Autism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10003484 Asperger's disorder PT
    14.1 10029205 - Nervous system disorders 10008520 Childhood autism LLT
    14.1 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) BE (Completed) ES (Completed) NL (Ongoing) EE (Completed) FR (Ongoing) IT (Completed) IS (Completed)
    Trial results: View results
    EudraCT Number: 2012-001616-33 Sponsor Protocol Number: MEM-MD-91 Start Date*: 2012-11-14
    Sponsor Name:Forest Research Institute, Inc.
    Full Title: An Open-Label Study Of The Safety And Tolerability Of Memantine In Pediatric Patients With Autism, Asperger’s Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Medical condition: Autism or Asperger’s Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10003484 Asperger's disorder PT
    14.1 10029205 - Nervous system disorders 10008520 Childhood autism LLT
    14.1 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) BE (Completed) ES (Completed) NL (Ongoing) EE (Completed) IS (Completed) IT (Completed)
    Trial results: View results
    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: 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: 2013-001694-24 Sponsor Protocol Number: D1050302 Start Date*: 2014-03-11
    Sponsor Name:SUNOVION PHARMACEUTICALS INC.
    Full Title: A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS WITH SCHIZOPHRENIA AND SUBJECTS WITH IRRIT...
    Medical condition: SCHIZOPHRENIA AND IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039628 Schizophrenia and other psychotic disorders HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) IT (Prematurely Ended) BG (Completed) Outside EU/EEA HU (Completed) GB (Completed) DE (Completed) PL (Completed) BE (Completed) FR (Ongoing)
    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: 2004-003941-42 Sponsor Protocol Number: B4Z-SO-LY15 Start Date*: 2005-02-11
    Sponsor Name:Eli Lilly Sweden AB
    Full Title: A Randomised, Double Blind Placebo Controlled Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Swedish Children and ...
    Medical condition: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common psychiatric disorder that has its onset in childhood, and that is estimated to occur in 3% to 6% of school-age children. ADHD is characte...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2022-000933-18 Sponsor Protocol Number: HLSC-UCD-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Unicyte AG
    Full Title: An Open-label, Non-controlled, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of Allogeneic Human Liver Stem Cells (HLSCs) in the Treatment of Pediatric Patients with Early-onset Ure...
    Medical condition: Urea cycle disorders
    Disease: Version SOC Term Classification Code Term Level
    21.1 200000003094 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021884-34 Sponsor Protocol Number: PERS3 Start Date*: 2013-01-24
    Sponsor Name:Radboud University Medical Centre Nijmegen
    Full Title: Relapse prevention in children and adolescents with DSM-IV Conduct Disorder treated with Risperidone: a Randomized Double blind, Placebo-Controlled, Discontinuation Study.
    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) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002423-36 Sponsor Protocol Number: S66832 Start Date*: 2023-05-30
    Sponsor Name:KU Leuven
    Full Title: Evaluation of oxytocin treatment in children with autism and intellectual disability
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10067989 Intellectual disability PT
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004345-32 Sponsor Protocol Number: ANAVEX2-73-RS-002 Start Date*: 2020-05-26
    Sponsor Name:Anavex Germany GmbH
    Full Title: A Double-Blind, Randomised, Placebo-Controlled, Safety and Efficacy Study of ANAVEX2-73 in Patients with Rett Syndrome
    Medical condition: Rett Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-004532-30 Sponsor Protocol Number: MRZ60201_3091_1 Start Date*: 2014-12-09
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of...
    Medical condition: Chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10039424 Salivary hypersecretion PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-000533-22 Sponsor Protocol Number: LAL-CL08 Start Date*: 2014-05-28
    Sponsor Name:Alexion Pharmaceuticals Inc
    Full Title: A Phase 2, Open Label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Sebelipase Alfa in Infants with Rapidly Progressive Lysosomal Acid Lipase Deficiency
    Medical condition: Lysosomal Acid Lipase Deficiency (LALD)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10024579 Lysosomal storage disorders HLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2021-003250-23 Sponsor Protocol Number: 78162.018.21 Start Date*: 2025-01-24
    Sponsor Name:Amsterdam UMC
    Full Title: Cannabidiol (Epidyolex) for behavioural problems in patients with Tuberous Sclerosis Complex, Sanfilippo and Fragile X Syndrome: an N-of-1 series
    Medical condition: Tuberous Sclerosis Complex (TSC), Sanfilippo syndrome, Fragile X syndrome (FXS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    20.0 10010331 - Congenital, familial and genetic disorders 10027424 Metabolic and nutritional disorders congenital HLGT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006536-22 Sponsor Protocol Number: N01263 Start Date*: 2011-07-05
    Sponsor Name:UCB Pharma SA
    Full Title: OPEN-LABEL, SINGLE-ARM, MULTICENTER, PHARMACOKINETIC, SAFETY, AND EFFICACY STUDY OF ADJUNCTIVE ADMINISTRATION OF BRIVARACETAM IN SUBJECTS FROM ≥1 MONTH TO <16 YEARS OLD WITH EPILEPSY
    Medical condition: Localization-related, generalized or undetermined whether focal or generalized epileptic syndrome, according to ILAE classification
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) ES (Completed) PL (Completed) Outside EU/EEA
    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)
    EudraCT Number: 2009-015768-33 Sponsor Protocol Number: EMR700773-003/BMN162-503 Start Date*: 2011-01-04
    Sponsor Name:BioMarin International Ltd.
    Full Title: A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan®) in Phenylketonuria (PKU) Patient...
    Medical condition: Phenylketonuria
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10034873 Phenylketonuria (PKU) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) SK (Completed) DE (Completed) AT (Completed) CZ (Completed) PT (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000499-24 Sponsor Protocol Number: 200722 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
    Medical condition: preterm labour and improve neonatal health
    Disease: Version SOC Term Classification Code Term Level
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) ES (Completed) SE (Completed) DE (Completed) IT (Completed) FR (Ongoing)
    Trial results: View results
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