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Clinical trials for GMFCS

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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    28 result(s) found for: GMFCS. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2009-009868-31 Sponsor Protocol Number: 80-82310-98-09088 Start Date*: 2009-06-18
    Sponsor Name:ZonMW
    Full Title: Quality of life, gross motor function, and actual everyday physical activity level in children with spastic Cerebral Palsy: (cost)effectiveness of combined treatment with multilevel botulinum-toxin...
    Medical condition: Spastic Cerebral Palsy, GMFCS levels I-III
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000222-19 Sponsor Protocol Number: H2020-PHC-18-2015-667224 Start Date*: 2017-08-02
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome – a blinded randomized placebo-controlled parallel group multicenter trial for superiori...
    Medical condition: Perinatal Asphyxia, hypoxic-ischemic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    20.0 10029205 - Nervous system disorders 10014633 Encephalopathy neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) NO (Trial now transitioned) ES (Ongoing) FI (Trial now transitioned) EE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) PT (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-005055-17 Sponsor Protocol Number: MRZ60201_3071_1 Start Date*: 2013-09-26
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Open-label, non-controlled, multicenter long-term study to investigate the safety and efficacy of Xeomin® (incobotulinumtoxin A, NT 201) for the treatment of spasticity of the lower limb(s) or of c...
    Medical condition: Lower limb and combined lower limb and upper limb spasticity due to cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10058977 Spastic paresis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) EE (Completed) SK (Completed) CZ (Completed) Outside EU/EEA FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2013-002896-17 Sponsor Protocol Number: V1.17.05.2013 Start Date*: Information not available in EudraCT
    Sponsor Name:Orthopädisches Spital Speising
    Full Title: Functional evaluation of two therapy concepts: dynamic orthoses and BoNT
    Medical condition: Infantile cerebral palsy
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-005049-21 Sponsor Protocol Number: MRZ-R-201212_01001_N_2 Start Date*: 2017-01-12
    Sponsor Name:LLC Merz Pharma, Russia
    Full Title: Multi-center Open Comparative Randomized Trial of Clinical and Neurophysiological Efficacy and Safety of Xeomin (Botulinum Toxin Type A) vs. Botox (Complex of Botulinum Toxin Type A and Hemaggluti...
    Medical condition: • Cerebral Palsy • Spastic Paraplegia and Hemiparesis • Equine and Equinovarus Foot Deformation
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-004584-19 Sponsor Protocol Number: version 22_06_2008_v2 Start Date*: 2008-09-30
    Sponsor Name:University hospital of Hvidovre
    Full Title: Skolioser hos cerebral parese patienter behandlet med Botulinum toxin A Injektioner.
    Medical condition: Scoliosis in patients with cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039722 Scoliosis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002997-18 Sponsor Protocol Number: 53975 Start Date*: 2017-03-14
    Sponsor Name:University Medical Center Utrecht, the Netherlands
    Full Title: Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
    Medical condition: Perinatal Arterial Ischemic Stroke (PAIS)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000084-24 Sponsor Protocol Number: 191622-112 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment of Pediatric Lower Limb Spasticity: Open-label Study
    Medical condition: Lower Limb Spasticity
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    14.1 10029205 - Nervous system disorders 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003559-12 Sponsor Protocol Number: INCIPIT Start Date*: 2021-01-27
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
    Full Title: Prospective, open-label, non-randomized, single-arm, dose titration study to investigate the efficacy and safety of IncobotulinumtoxinA in children deemed to require a total body dose up to 22U/kg ...
    Medical condition: Multifocal spasticity of the upper and lower limb due to cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    20.0 100000004850 10033560 Palsy cerebral LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002539-32 Sponsor Protocol Number: The_WE_Study Start Date*: 2015-03-23
    Sponsor Name:St. Olavs University Hospital
    Full Title: The WE Study - Walking Easier with cerebral palsy
    Medical condition: cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10021740 Infantile cerebral palsy LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) FR (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-019768-35 Sponsor Protocol Number: ITB2010 Start Date*: 2012-07-27
    Sponsor Name:
    Full Title: Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial
    Medical condition: dytonic cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10008129 Cerebral palsy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023240-33 Sponsor Protocol Number: POPPIES Start Date*: 2011-04-21
    Sponsor Name:Guys and St Thomas' NHS Foundation Trust
    Full Title: Post-operative pain in children with cerebral palsy following major hip surgery: a double blind randomised placebo controlled trial of pre-operative Botulinum toxin type A. [The Post-Operative Pain...
    Medical condition: Post Operative Pain in Cerebral Palsy
    Disease: Version SOC Term Classification Code Term Level
    10054710 Post Operative Hip Pain LLT
    10008129 Cerebral Palsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-004474-42 Sponsor Protocol Number: V3_06082015 Start Date*: 2015-05-07
    Sponsor Name:Copenhagen University Hospital at Hvidovre
    Full Title: Treatment of equinus gait caused by dynamic tightening of the calf muscles in children with cerebral palsy. A randomized, placebo controlled Botulinum toxin type A volume/response study.
    Medical condition: Treatment of equinus gait caused by dynamic tightening of the calf muscles in children with cerebral palsy.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004859 10015112 Equinus deformity of foot, acquired LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002499-42 Sponsor Protocol Number: Version1on02-02-2018 Start Date*: 2018-08-29
    Sponsor Name:Cliniques Universitaires Saint-Luc
    Full Title: Evaluation of the effect of repeated injections of high doses of botulinum toxin into the lower limb of spastic brain lesions on functional and biomechanical parameters of walking
    Medical condition: Patients with spastic brain lesions. Children with cerebral palsy (CP) and in the hemiplegic adult.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001438-25 Sponsor Protocol Number: VWM1 Start Date*: 2020-04-21
    Sponsor Name:VU University Medical Center
    Full Title: A Study to Explore the Safety, Tolerability, Pharmacokinetic Profile, and Potential Efficacy of Guanabenz in Patients With Early Childhood Onset Vanishing White Matter (VWM)
    Medical condition: Vanishing white matter
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-017709-12 Sponsor Protocol Number: Y-55-52120-141 Start Date*: Information not available in EudraCT
    Sponsor Name:Ipsen Pharma SAS
    Full Title: A PHASE III, MULTICENTRE, DOUBLE BLIND, PROSPECTIVE, RANDOMISED, PLACEBO CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF DYSPORT USED IN THE TREATMENT OF LOWER LIMB SPASTICITY IN CHILDREN WIT...
    Medical condition: Lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10024132 Leg spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) PL (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2012-003771-18 Sponsor Protocol Number: GWSP08258 Start Date*: 2013-08-06
    Sponsor Name:GW Pharma Ltd.
    Full Title: The efficacy, safety and tolerability of Sativex as an adjunctive treatment to existing anti-spasticity medications in children aged 8 to 18 years with spasticity due to cerebral palsy or traumatic...
    Medical condition: Spasticity due to cerebral palsy (CP) or traumatic central nervous system injury.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2022-000064-21 Sponsor Protocol Number: TPN-101-AGS-201 Start Date*: 2022-09-20
    Sponsor Name:Transposon Therapeutics Inc
    Full Title: A Phase 2a Study of TPN-101 in Patients with Aicardi-Goutières Syndrome (AGS)
    Medical condition: Aicardi-Goutières Syndrome (AGS)
    Disease: Version SOC Term Classification Code Term Level
    22.1 10010331 - Congenital, familial and genetic disorders 10083189 Aicardi-Goutieres syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001634-18 Sponsor Protocol Number: M602011072 Start Date*: Information not available in EudraCT
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: A prospective, randomized, double-blind, placebo-controlled, two-stage, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of lo...
    Medical condition: Pediatric lower limb (LL) spasticity (SP) caused by cerebral palsy (CP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10041416 Spasticity LLT
    21.1 100000004852 10024132 Leg spasticity LLT
    20.1 100000004850 10021740 Infantile cerebral palsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) LV (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000062-38 Sponsor Protocol Number: 191622-101 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study
    Medical condition: Upper Limb Spasticity.
    Disease: Version SOC Term Classification Code Term Level
    15.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    15.1 10029205 - Nervous system disorders 10048970 Arm spasticity LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (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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