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Clinical trials for Spasticity

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   44380   clinical trials with a EudraCT protocol, of which   7392   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
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    Study title: EFFICACY OF DAILY INTRATHECAL BACLOFEN TO TREAT CHILDREN WITH SEVERE SPASTICITY
    Active substance: BACLOFEN
    Study summary document link (including results): baclofen-LIR 647A IT8 Art45 listing 2011.xls
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    Document reference: 22064
    Study title: A multicentre, double-blind, prospective, randomised, placebo controlled phase II study to assess the efficacy and safety of botulinum toxin A (Dysport) in the treatment of adductor muscle spasticity in children with cerebral palsy (CP).
    Active substance: Botulinum toxin A
    Study summary document link (including results):
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    Document reference: 22710
    Study title: A double-blind, prospective, randomised, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of Dysport with placebo in lower limb spasticity in children with cerebral palsy
    Active substance: Botulinum toxin A;
    Study summary document link (including results):
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    Document reference: 41068
    Study title: A retrospective, non-comparative study of the safety and efficacy of botulinum toxin A (Dysport) in the treatment of paediatric spasticity
    Active substance: Botulinum toxin A;
    Study summary document link (including results):
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    Document reference: 41070
    Study title: A double-blind, prospective, randomised, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of Dysport with placebo in lower limb spasticity in children with cerebral palsy
    Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX
    Study summary document link (including results):
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    Document reference: 24433
    Study title: A randomised, double-blind, placebo-controlled study to compare the efficacy and safety of Dysport with placebo in lower limb muscle spasticity in patients with spastic cerebral palsy
    Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX
    Study summary document link (including results):
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    Document reference: 24434
    Study title: An assessor-blind, prospective, randomised, chronic dosing study to compare the long-term efficacy and safety of two differing Dysport dosage regimens in the treatment of lower limb spasticity in children with cerebral palsy.
    Active substance: CLOSTRIDIUM BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX
    Study summary document link (including results):
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    Document reference: 24435
    Study title: Haslam RHA et al.:Dantrolene sodium in children with spasticity; Arch. Phys. Med. Rehabil. 55, 384-388 (1974)Haslam RHA et al.:Dantrolene sodium in children with spasticity; Arch. Phys. Med. Rehabil. 55, 384-388 (1974)
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25530
    Study title: Lewis, K.R.:Double-blind Controlled Evaluation of the Safety and Efficacy of Dantrolene Sodium in the Treatment of Moderate to Severe Skeletal Muscle Spasticity in a Pediatric Population;Lewis, K.R.:Double-blind Controlled Evaluation of the Safety and Efficacy of Dantrolene Sodium in the Treatment of Moderate to Severe Skeletal Muscle Spasticity in a Pediatric Population;
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25549
    Study title: Mayer N. et al: Treatment of spasticity with dantrolene sodium; Am. J. Phys. Med. 52, 18 (1973)Mayer N. et al: Treatment of spasticity with dantrolene sodium; Am. J. Phys. Med. 52, 18 (1973)
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25553
    Study title: Mejia, R.:Double-blind Controlled Evaluation of the Safety and Efficacy of Dantrolene Sodium in the Treatment of Moderate to Severe Skeletal Muscle Spasticity in a Pediatric Population;Mejia, R.:Double-blind Controlled Evaluation of the Safety and Efficacy of Dantrolene Sodium in the Treatment of Moderate to Severe Skeletal Muscle Spasticity in a Pediatric Population;
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25550
    Study title: Molnar GE et al.: Dantrolene sodium in spasticity. Long-term administration in children; N. Y. StateJ. Med. 78, 1233-1237 (1978)Molnar GE et al.: Dantrolene sodium in spasticity. Long-term administration in children; N. Y. StateJ. Med. 78, 1233-1237 (1978)
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25537
    Study title: Nogen AG: Medical treatment for spasticity in children with cerebral palsy; Childs Brain 2, 304-308 (1976)Nogen AG: Medical treatment for spasticity in children with cerebral palsy; Childs Brain 2, 304-308 (1976)
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25532
    Study title: Pozonyi, J.:Double-blind Controlled Evaluation of the Safety and Efficacy of Dantrolene Sodium in the Treatment of Moderate to Severe Skeletal Muscle Spasticity in a Pediatric Population;Pozonyi, J.:Double-blind Controlled Evaluation of the Safety and Efficacy of Dantrolene Sodium in the Treatment of Moderate to Severe Skeletal Muscle Spasticity in a Pediatric Population;
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25551
    Study title: Soboloff, H.R.:Single-blind Controlled Evaluation of the Safety and Efficacy of Dantrolene Sodium in the Treatment of Moderate to Severe Skeletal Muscle Spasticity in a Pediatric Population;Soboloff, H.R.:Single-blind Controlled Evaluation of the Safety and Efficacy of Dantrolene Sodium in the Treatment of Moderate to Severe Skeletal Muscle Spasticity in a Pediatric Population;
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25552
    Study title: Adams, E.D.:Double-blind controlled evaluation of the Safety and Effectiveness of Dantrolene Sodium in relieving Spasticity Associated with Dystonia in Children with Cerebral Palsy;Adams, E.D.:Double-blind controlled evaluation of the Safety and Effectiveness of Dantrolene Sodium in relieving Spasticity Associated with Dystonia in Children with Cerebral Palsy;
    Active substance: DANTROLENE
    Study summary document link (including results):
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    Document reference: 25547
    Study title: A 3-MONTH, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, SINGLE CENTER STUDY, TO EVALUATE THE EFFICACY AND SAFETY OF GABAPENTIN (CI-945) IN PATIENTS WITH SPASTICITY.
    Active substance: GABAPENTIN
    Study summary document link (including results):
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    Document reference: 28735
    Study title: Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6Utilidad de la tizanidina. Seguimiento de un ano en el tratamiento de la espasticidad en la paralysis (The usefulness of tizanidine. A one−year follow−up of the treatment of spasticity in infantile cerebral palsy). Vásquez BA, Arellano SME, León HSR, Morales OMG. Revista de neurologia, Aug 1−15 2006, vol. 43, no. 3, p. 132−6
    Active substance: TINZANIDINE
    Study summary document link (including results):
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    Document reference: 44790
    Study title: A double-blind comparative trial of Tizanidine and diazepam in the treatment of chronic spasticity in patients with hemiplegia
    Active substance: TIZANIDINE
    Study summary document link (including results):
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    Document reference: 44783
    Study title: A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group. Neurology, Nov 1994, vol. 44, no. 11 Suppl 9, p. S70−8A double−blind, placebo−controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group. Neurology, Nov 1994, vol. 44, no. 11 Suppl 9, p. S70−8
    Active substance: TIZANIDINE
    Study summary document link (including results):
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    Document reference: 38513
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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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