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Clinical trials for Spinal dysraphism

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   44366   clinical trials with a EudraCT protocol, of which   7389   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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    5 result(s) found for: Spinal dysraphism. Displaying page 1 of 1.
    EudraCT Number: 2007-006433-13 Sponsor Protocol Number: TNG-CL008 Start Date*: 2008-06-11
    Sponsor Name:Tengion Inc.
    Full Title: An open-label, multicentre study of augmentation cystoplasty using an autologous Neo-Bladder construct in subjects with spina bifida.
    Medical condition: Neurogenic bladder secondary to spina bifida
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029279 Neurogenic bladder LLT
    9.1 10041524 Spina bifida LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-005295-33 Sponsor Protocol Number: S54913 Start Date*: 2013-03-08
    Sponsor Name:UZ Leuven-Department of Urology
    Full Title: Monocentric, open-label, phase III study that compares the efficiency and tolerance between intravesical oxybutynin and oral fesoterodine in children (5-16y) with neurogenic detrusor overactivity.
    Medical condition: children with neurogenic detrusor overactivity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10041524 Spina bifida PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-003325-10 Sponsor Protocol Number: 1.01 Start Date*: 2012-08-10
    Sponsor Name:VU University Medical Center
    Full Title: A randomized controlled trail on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth
    Medical condition: congenital anomalies
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10004953 Birth premature LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10007607 Cardiac septal defects congenital HLT
    14.1 10010331 - Congenital, familial and genetic disorders 10041524 Spina bifida PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000676-11 Sponsor Protocol Number: URO-901-3007 Start Date*: 2022-12-30
    Sponsor Name:Urovant Sciences GmbH
    Full Title: A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age with...
    Medical condition: Neurogenic Detrusor Overactivity (NDO)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10029279 Neurogenic bladder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Trial now transitioned) SK (Trial now transitioned) NO (Prematurely Ended) LV (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) PL (Ongoing) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-004877-26 Sponsor Protocol Number: 191622-120 Start Date*: 2013-07-18
    Sponsor Name:Allergan Ltd.
    Full Title: BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
    Medical condition: Urinary Incontinence Due to Neurogenic Detrusor Overactivity
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10046543 Urinary incontinence PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) AT (Completed) IT (Completed) DE (Completed) PL (Completed) FR (Completed)
    Trial results: View results
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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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