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Clinical trials for Socialization

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   44358   clinical trials with a EudraCT protocol, of which   7384   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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    16 result(s) found for: Socialization. Displaying page 1 of 1.
    EudraCT Number: 2016-004325-16 Sponsor Protocol Number: RC31/16/8407 Start Date*: 2016-12-22
    Sponsor Name:University Hospital of Toulouse
    Full Title: Long term evaluation of infants aged from 3 to 4 years old included in the OTBB2 study (repeated administrations of oxytocin in infants with PWS aged from 0 to 6 months) and comparison with not tre...
    Medical condition: Prader Willi Syndrom
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003173-22 Sponsor Protocol Number: BP30153 Start Date*: 2020-11-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A Phase II Multi-Center, Randomized, Double-Blind, 24-Week, Parallel Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Children and Adolescents Age...
    Medical condition: Autism Spectrum Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-000243-33 Sponsor Protocol Number: FARM68SY5C Start Date*: 2008-09-24
    Sponsor Name:ISTITUTO SUPERIORE DI SANITA'
    Full Title: Alzheimer disease and antipsycotics: a long term multicenter randomized clinical trial
    Medical condition: BPSD in Alzheimer disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004209 Behaviour and socialisation disturbances HLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-002907-17 Sponsor Protocol Number: OV101-19-001 Start Date*: 2020-02-19
    Sponsor Name:Ovid Therapeutics Inc.
    Full Title: A MulticeNter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in PediaTric IndividUals With AngelmaN SyndromE (NEPTUNE)
    Medical condition: Angelman Syndrome
    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 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004378-32 Sponsor Protocol Number: WN39434 Start Date*: 2018-09-26
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A phase III, randomized, double-blind, placebo-controlled, efficacy, and safety study of Balovaptan in adults with Autism Spectrum Disorder with a 2 year open-label extension.
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    21.1 10037175 - Psychiatric disorders 10034739 Pervasive developmental disorder NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002885-38 Sponsor Protocol Number: HGT-HIT-094 Start Date*: 2013-10-22
    Sponsor Name:Shire HGT Inc
    Full Title: A Controlled,Randomized,Two-arm,Open-label,Assessor-blinded,Multicenter Study of Intrathecal Idursulfase-IT Administered in Conjunction with Elaprase® in Pediatric Patients with Hunter Syndrome and...
    Medical condition: Long-term treatment of Hunter syndrome and cognitive impairment
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    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: 2018-000942-21 Sponsor Protocol Number: AIMS-2-CT1 Start Date*: 2019-07-24
    Sponsor Name:Celso Arango
    Full Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents w...
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    20.0 10037175 - Psychiatric disorders 10003805 Autism LLT
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-003067-59 Sponsor Protocol Number: AOB/2013/01 Start Date*: 2017-01-25
    Sponsor Name:AZIENDA OSPEDALIERA G. BROTZU
    Full Title: A single-center, randomized, double-blind, placebo-controlled, cross-over study of intranasal oxytocin in young adults with Autism Spectrum Disorder
    Medical condition: Autism Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10003805 Autism LLT
    Population Age: Adults Gender: Male
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003524-20 Sponsor Protocol Number: BP41316 Start Date*: 2020-12-15
    Sponsor Name:F. HOFFMANN - LA ROCHE LTD.
    Full Title: A phase II multicenter, randomized, double-blind, 12-week treatment, 3-arm, parallel-group, placebo-controlled study to investigate the efficacy, safety and tolerability of RO7017773 in participant...
    Medical condition: Autism Spectrum Disorder (ASD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004804-31 Sponsor Protocol Number: SHP-ELA-401 Start Date*: 2016-04-12
    Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire), a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
    Full Title: A Long-Term, Open-Label, Multicenter, Phase IV Study to Assess Longitudinal Changes on Height and Weight in Patients with MPS II Who Are Receiving Elaprase and Started Treatment With Elaprase at <6...
    Medical condition: Hunter syndrome (Mucopolysaccharidosis II, [MPS II])
    Disease:
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001839-77 Sponsor Protocol Number: 5mille_CT1 Start Date*: 2022-04-26
    Sponsor Name:IRCCS MATERNO INFANTILE BURLO GAROFOLO
    Full Title: A Multicentric, Drug-Repositioning, Self Controlled Case Series (SCCS) Clinical Trial to Evaluate the Efficacy and Safety of Perampanel in Improving Behavioral Symptoms and Increasing the Quality o...
    Medical condition: Patients with POGZ related disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10037173 Psychiatric and behavioural symptoms NEC HLGT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004478-24 Sponsor Protocol Number: OV101-18-002 Start Date*: 2020-06-05
    Sponsor Name:Ovid Therapeutics Inc.
    Full Title: An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA)
    Medical condition: Angelman Syndrome
    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: DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-005387-22 Sponsor Protocol Number: ACP-103-069 Start Date*: 2022-06-27
    Sponsor Name:Acadia Pharmaceuticals Inc.
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
    Medical condition: Treatment of irritability associated with autistic disorder in children and adolescents with ASD
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Completed) HU (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-002762-33 Sponsor Protocol Number: AX250-401 Start Date*: 2022-12-12
    Sponsor Name:Allievex Corporation
    Full Title: A Phase 3B/4 Open-Label Multicenter Study Extension Study to Further Evaluate Safety, Tolerability and Efficacy of Intracerebroventricular AX 250 Treatment in Mucopolysaccharidosis Type IIIB (MPS I...
    Medical condition: Mucopolysaccharidosis Type IIIB (Sanfilippo Syndrome Type B, MPS IIIB)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    20.0 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001363-27 Sponsor Protocol Number: DAY101-002 Start Date*: 2023-01-18
    Sponsor Name:Day One Biopharmaceuticals, Inc. (Day One)
    Full Title: LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activati...
    Medical condition: Pediatric low-grade glioma harboring an activating RAF alteration requiring first-line systemic therapy
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065443 Malignant glioma PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) IE (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned) FI (Trial now transitioned) AT (Trial now transitioned) SI (Trial now transitioned) GR (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned)
    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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