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Clinical trials for Developmental regression

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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    9 result(s) found for: Developmental regression. Displaying page 1 of 1.
    EudraCT Number: 2013-000531-27 Sponsor Protocol Number: NL43510 Start Date*: 2014-02-11
    Sponsor Name:University Medical Center Utrecht
    Full Title: Corticosteroids or clobazam for ESES syndrome: a European, multicenter, randomized, controlled clinical trial
    Medical condition: Encephalopathy with electrical status epilepticus in sleep, also called ESES syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032061 Other forms of epilepsy LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) FI (Completed) ES (Prematurely Ended) BE (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) FR (Ongoing) DK (Completed) IT (Ongoing)
    Trial results: View results
    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: 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: 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: 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: 2018-000195-15 Sponsor Protocol Number: P4-SAF-302 Start Date*: 2018-12-27
    Sponsor Name:Lysogene SA
    Full Title: An Open-Label, Single-Arm, Multicenter Study of Intracerebral Administration of Adeno-Associated Viral Vectors Serotype rh10 Carrying the Human N-sulfoglucosamine sulfohydrolase (SGSH) cDNA for the...
    Medical condition: Mucopolysaccharidosis Type IIIA
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) NL (Temporarily Halted) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-002314-17 Sponsor Protocol Number: JR-441-101 Start Date*: 2023-07-03
    Sponsor Name:JCR Pharmaceuticals Co., Ltd.
    Full Title: Phase I/II study of weekly infusions of JR-441 in patients with mucopolysaccharidosis type IIIA
    Medical condition: Mucopolysaccharidosis type IIIA (MPS IIIA) MPS III is an autosomal recessive disease characterized by the accumulation of HS in the tissues throughout the body due to a deficiency in enzymes involv...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    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: 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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