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Clinical trials for Developmental disorders

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    115 result(s) found for: Developmental disorders. Displaying page 3 of 6.
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    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: 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: 2013-000389-12 Sponsor Protocol Number: 3.0 Start Date*: 2013-09-11
    Sponsor Name:Cardiff University
    Full Title: ANti-psychotic Drug REduction in primary care for Adults with Learning Disabilities (ANDREA-LD): A Randomised Double-blind Placebo Controlled Trial
    Medical condition: Aggression and challenging behaviour in adults with learning disabilities
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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: 2017-001903-60 Sponsor Protocol Number: EFC14643 Start Date*: 2018-07-04
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Famil...
    Medical condition: Hypercholesterolaemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020603 Hypercholesterolaemia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) FR (Completed) IT (Completed) DE (Completed) AT (Completed) Outside EU/EEA NL (Completed) HU (Completed) SI (Completed) ES (Completed) PL (Completed) FI (Completed) BG (Completed) CZ (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2014-000586-45 Sponsor Protocol Number: S56327 Start Date*: 2014-05-08
    Sponsor Name:KU Leuven
    Full Title: Oxytocin-based pharmacotherapy for Autism Spectrum Disorders: Investigating the neural and behavioral effects of a promising intervention approach
    Medical condition: Young male adults with Autism Spectrum Disorders (18-30 years)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004852 10003808 Autistic disorder LLT
    Population Age: Adults Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001983-20 Sponsor Protocol Number: NGLU-CL01-T Start Date*: 2015-08-06
    Sponsor Name:Alexion Pharmaceuticals, Inc
    Full Title: A Phase I/II Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Int...
    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)
    Trial results: View results
    EudraCT Number: 2013-002702-30 Sponsor Protocol Number: ALXN1101-MCD-202 Start Date*: Information not available in EudraCT
    Sponsor Name:Origin Biosciences, Inc.
    Full Title: A PHASE 2/3, MULTICENTER, MULTINATIONAL, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALXN1101 IN NEONATES WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A
    Medical condition: Molydenum CoFactor Deficiency (MoCD) Type A
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10069687 Molybdenum cofactor deficiency PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Completed) FR (Completed) IT (Prematurely Ended) NO (Completed)
    Trial results: View results
    EudraCT Number: 2022-000565-40 Sponsor Protocol Number: GLM101-002 Start Date*: 2022-11-04
    Sponsor Name:Glycomine, Inc
    Full Title: A Phase 2, Randomized, Open-Label, 12-Week Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GLM101 Administered Intravenously to Adult Participa...
    Medical condition: PMM2-CDG
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10027426 Metabolic disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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: 2018-004216-22 Sponsor Protocol Number: C602 Start Date*: 2019-09-25
    Sponsor Name:Soleno Therapeutics UK Ltd.
    Full Title: An Open-Label, Long-Term Safety and Efficacy Evaluation of Diazoxide Choline Controlled-Release Tablet in Patients with Prader-Willi Syndrome
    Medical condition: Hyperphagia associated with Prader-Willi Syndrome (PWS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10020710 Hyperphagia PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-003009-23 Sponsor Protocol Number: ION582-CS1 Start Date*: 2022-07-19
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION582 in Patients with Angelman Syndrome
    Medical condition: Angelman syndrome is a neurogenetic disorder caused by a loss of function of the maternally inherited UBE3A gene (chromosome 15) which codes for UBE3A ubiquitin protein ligase. AS presents early in...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10049004 Angelman's syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Trial now transitioned) NL (Ongoing)
    Trial results: (No results available)
    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: 2015-005176-17 Sponsor Protocol Number: BP-I-008 Start Date*: 2016-10-20
    Sponsor Name:Bellicum Pharmaceuticals, Inc.
    Full Title: A Phase I Study of Safety, Pharmacokinetics and Efficacy of Donor BPX-501 Cells and AP1903 Infusion for Children with Recurrent or Minimal Residual Disease Hematologic Malignancies After Allogeneic...
    Medical condition: recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10018849 Haematological disorders NEC HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    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: 2021-003222-76 Sponsor Protocol Number: ZX008-2103 Start Date*: 2022-08-19
    Sponsor Name:Zogenix International Limited
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, FIXED-DOSE, MULTICENTER STUDY TO EXAMINE THE EFFICACY AND SAFETY OF ZX008 IN SUBJECTS WITH CDKL5 DEFICIENCY DISORDER FOLLOWED BY AN OPEN-LABE...
    Medical condition: CDKL5 DEFICIENCY DISORDER
    Disease: Version SOC Term Classification Code Term Level
    22.1 10010331 - Congenital, familial and genetic disorders 10083005 CDKL5 deficiency disorder PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PT (Trial now transitioned) DE (Trial now transitioned) FR (Not Authorised) NL (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) IE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002155-28 Sponsor Protocol Number: P160902J Start Date*: 2018-08-30
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Evaluation of allopurinol treatment for autistic disorders and epilepsy in adenylosuccinate lyase deficiency (ADSL)
    Medical condition: patient with adenulosuccinate lyase deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10062018 Inborn error of metabolism PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000867-21 Sponsor Protocol Number: NGAM-13 Start Date*: 2021-08-16
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: A Superiority Study To Compare The Effect of Panzyga Versus Placebo in Patients with Pediatric Acute-onset Neuropsychiatric Syndrome
    Medical condition: Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). PANS is a research diagnosis given to patients who have an abrupt, dramatic onset of neuropsychiatric symptoms including obsessions/compulsio...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004143-13 Sponsor Protocol Number: SHP-609-302 Start Date*: 2015-03-19
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: An Open Label Extension of Study HGT-HIT-094 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Idursulfase Administered in Conjunction with Elaprase® in Patients with Hunter Syndrome...
    Medical condition: Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    20.0 10010331 - Congenital, familial and genetic disorders 10056917 Hunter's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-004478-80 Sponsor Protocol Number: Issue1 Start Date*: 2014-01-08
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: XENON AND COOLING THERAPY IN BABIES AT HIGH RISK OF BRAIN INJURY FOLLOWING POOR CONDITION AT BIRTH: A RANDOMISED OUTCOME STUDY (COOLXENON3 STUDY)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    16.1 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
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