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Clinical trials for Spina Bifida

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   44334   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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    11 result(s) found for: Spina Bifida. 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: 2013-003842-18 Sponsor Protocol Number: A301223 Start Date*: 2014-04-24
    Sponsor Name:Erasmus MC
    Full Title: Prevention of renal and bladder damage in children with spina bifida by means of early injections with Botulinum-Toxin-A (Botox): a pilot study.
    Medical condition: Neurogenic bladder function disease in spina bifida patients.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10030685 Open spina bifida LLT
    16.1 100000004850 10041531 Spina bifida without mention of hydrocephalus LLT
    16.1 100000004857 10029280 Neurogenic bladder, not otherwise specified LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    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: 2006-004749-40 Sponsor Protocol Number: PEDMet 2006-1 Start Date*: 2006-11-20
    Sponsor Name:Pediatrics
    Full Title: Glucose metabolism in patients with neurological/neuromuscular diseases.
    Medical condition: Patients with neurological/neuromuscular diseases
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022475-55 Sponsor Protocol Number: A0221047 Start Date*: 2012-07-20
    Sponsor Name:Pfizer Inc.235 East 42nd Street, New York, NY 10017
    Full Title: A 24-WEEK RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDI...
    Medical condition: Neurogenic Detrusor Overactivity (NDO).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038359 - Renal and urinary disorders 10029279 Neurogenic bladder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) EE (Completed) FI (Completed) SK (Completed) GB (Completed) ES (Completed) GR (Completed) FR (Completed) NL (Completed) BE (Completed) RO (Ongoing) DK (Prematurely Ended) DE (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003048-52 Sponsor Protocol Number: 527.51 Start Date*: 2007-10-29
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Phase IIb/III, multi-centre, double-blind, randomised, placebo-controlled, dose ranging study of tamsulosin hydrochloride (low, medium and high dose) as treatment in children with neuropathic bla...
    Medical condition: Neurogenic Bladder
    Disease: Version SOC Term Classification Code Term Level
    8.1 10029279 Neurogenic bladder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-004423-11 Sponsor Protocol Number: 527.66 Start Date*: 2007-01-22
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: An uncontrolled, open-label, titration, long-term safety (up to 12 months) and efficacy study of tamsulosin hydrochloride in children with neuropathic bladder, with a randomized pharmacokinetic sub...
    Medical condition: Neurogenic Bladder
    Disease: Version SOC Term Classification Code Term Level
    8.1 10029279 Neurogenic bladder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-004641-27 Sponsor Protocol Number: UZLeuven Start Date*: Information not available in EudraCT
    Sponsor Name:UZLeuven
    Full Title: BOTOX in the treatment of urinary incontinence due to neurogenic detrusor overactivity in patients 3 months - 17 years
    Medical condition: Urinary incontinence due to neurogenic detrusor overactivity
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038359 - Renal and urinary disorders 10029279 Neurogenic bladder PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    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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