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Clinical trials for Spastic cerebral palsy

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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    20 result(s) found for: Spastic cerebral palsy. Displaying page 1 of 1.
    EudraCT Number: 2015-000095-10 Sponsor Protocol Number: BATCP Start Date*: 2015-03-30
    Sponsor Name:Karolinska Institutet
    Full Title: Botulinum toxin-A as a treatment for chronic muscle-related pain in adults with spastic cerebral palsy: a randomized controlled trial.
    Medical condition: Spastic cerebral palsy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-005538-23 Sponsor Protocol Number: RB15.213 Start Date*: 2016-02-03
    Sponsor Name:CHRU de Brest
    Full Title: Analgesia and physiotherapy in children with cerebral palsy (ANTALKINECP): Double blind cross-over placebo controlled study of Ibuprofen in children with cerebral palsy undergoing physiotherapy
    Medical condition: Cerebral Palsy
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10008129 Cerebral palsy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (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: 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: 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: 2008-000833-23 Sponsor Protocol Number: BACLOFENE INTRATECALE Start Date*: 2008-02-26
    Sponsor Name:AZIENDA OSPEDALIERA ISTITUTI CLINICI DI PERFEZIONAMENTO DI MILANO
    Full Title: Efficacy evaluation of oral baclofen treatment versus intrathecal baclofen in children with dystonic cerebral palsy
    Medical condition: Dystonic or spastic dystonic cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029205 SOC
    9.1 10008129 PT
    9.1 10021740 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004685-17 Sponsor Protocol Number: ERA2005neuro Start Date*: 2005-11-16
    Sponsor Name:CUB - Hôpital Erasme
    Full Title: A prospective placebo controlled study of botulilium toxin (BOTOX) on gait disorder induced by spastic equinovarus foot.
    Medical condition: Spastic equinus foot is a common dynamic deformity in patients with cerebral palsy. This dynamic deformity, mainly caused by spasticity of the soleus, gastrocnemius and tibialis posterior muscles, ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    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: 2017-004497-33 Sponsor Protocol Number: Protocol_Dysport_v3__13.12.2017 Start Date*: 2018-03-06
    Sponsor Name:Copenhagen University Hospital at Hvidovre
    Full Title: Measuring effects on pain and quality of life after Dysport® injection in children with cerebral palsy
    Medical condition: Muscle pain in the extremities due to spasticity in children with cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10028322 Muscle pain LLT
    20.0 100000004852 10041418 Spasticity muscle LLT
    20.1 100000004850 10021745 Infantile cerebral palsy, unspecified LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-015620-29 Sponsor Protocol Number: 2009/1314 Start Date*: 2010-03-08
    Sponsor Name:
    Full Title: The efficacy of the Botulinum toxin-A on the manual abilities in children with congenital spastic hemiplegia. Interest of the measure of the bimanual task performance.
    Medical condition: The main objective of this study is to investigate the effect of Botulinum toxin A to improve the Upper Limb dysfunction in Hemiplegic Cerebral Palsy Children and in particular, its impact on Up...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10019475 Hemiplegic infantile cerebral palsy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005496-14 Sponsor Protocol Number: MRZ60201_3072_1 Start Date*: Information not available in EudraCT
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, multicenter, randomized, double-blind, parallel-group, dose-response study of three doses Xeomin® (incobotulinumtoxinA, NT 201) for the treatment of upper limb spasticity alone or comb...
    Medical condition: Upper limb spasticity or combined upper and lower limb spasticity in children and adolescents (age 2 - 17 years) with cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10058977 Spastic paresis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) Outside EU/EEA
    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: 2012-005054-30 Sponsor Protocol Number: MRZ60201_3070_1 Start Date*: 2013-04-08
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, multicenter, randomized, double-blind, parallel-group, dose-response study of three doses Xeomin® (incobotulinumtoxinA, NT 201) for the treatment of lower limb spasticity in children a...
    Medical condition: Lower limb spasticity due to cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10058977 Spastic paresis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) AT (Completed) DE (Completed) SK (Completed) CZ (Completed) ES (Completed) Outside EU/EEA FR (Ongoing)
    Trial results: View results
    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: 2012-005055-17 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: 2006-002175-40 Sponsor Protocol Number: no number Start Date*: 2008-12-17
    Sponsor Name:
    Full Title: Effect of Botulinum Toxin A Injections and Specific Intensive Rehabilitation Therapy in Children with Hemiparetic Cerebral Palsy on Upper Limb Functions and Skills
    Medical condition: Study design: a factorial design with four study groups in which btA alone, intensive rehabilitation therapy aimed at improving bimanual skills alone, a combination of these two and continuing the ...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    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
    EudraCT Number: 2012-000042-35 Sponsor Protocol Number: 191622-111 Start Date*: 2013-07-08
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind 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: 2012-000043-27 Sponsor Protocol Number: 191622-105 Start Date*: Information not available in EudraCT
    Sponsor Name:Allergan Limited
    Full Title: BOTOX® Treatment in Pediatric Upper Limb Spasticity: Open-label Study
    Medical condition: Upper 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 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
    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
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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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