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Clinical trials for Spastic paresis

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   44336   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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    7 result(s) found for: Spastic paresis. Displaying page 1 of 1.
    EudraCT Number: 2010-023043-15 Sponsor Protocol Number: MRZ60201/SP/3001 Start Date*: 2011-09-14
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, double-blind, placebo-controlled, randomized, multi-center study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of post-stroke sp...
    Medical condition: post-stroke spasticity of the upper limb
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10058977 Spastic paresis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2010-020886-26 Sponsor Protocol Number: MRZ60201_3053_1 Start Date*: 2011-12-15
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, open-label, non-randomized, single-arm, multi-center dose titration study to investigate the safety and efficacy of NT 201 in subjects deemed to require total body doses of 800 U of NT...
    Medical condition: Spasticity of the upper and lower limb of the same body side due to cerebral causes
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004852 10058977 Spastic paresis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) PT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-024579-23 Sponsor Protocol Number: MRZ60201/SP/3002 Start Date*: 2012-02-06
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, double-blind, placebo-controlled, randomized, multi-center study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of post-stroke sp...
    Medical condition: post-stroke spasticity of the lower limb
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004852 10058977 Spastic paresis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) CZ (Completed) ES (Completed) PL (Completed) IT (Completed) HU (Prematurely Ended)
    Trial results: View results
    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: 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: 2018-001639-35 Sponsor Protocol Number: M602011014 Start Date*: 2019-11-26
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic...
    Medical condition: Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10058977 Spastic paresis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) NO (Completed) CZ (Trial now transitioned) GB (GB - no longer in EU/EEA) ES (Ongoing) IT (Trial now transitioned) HU (Trial now transitioned) SK (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
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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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