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Clinical trials for Intrathecal baclofen pump

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
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    • 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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    6 result(s) found for: Intrathecal baclofen pump. Displaying page 1 of 1.
    EudraCT Number: 2008-004934-26 Sponsor Protocol Number: N/A Start Date*: 2008-11-26
    Sponsor Name:UMCG
    Full Title: Pharmacokinetics and –dynamics of intrathecal baclofen therapy in patients with spasticity
    Medical condition: Spasticity of varying origin (i.e. MS, spinal cord injury), which doesn't respond on treatment with oral medication
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041416 Spasticity LLT
    9.1 10024132 Leg spasticity LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004994-30 Sponsor Protocol Number: NL68837.091.21 Start Date*: 2022-02-08
    Sponsor Name:Roessingh
    Full Title: Pulmonary function and sleep related disorders during cervical admission of intrathecal baclofen in spinal cord injury; a safety study
    Medical condition: Spasticity in patients with spinal cord injury
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-002565-39 Sponsor Protocol Number: 2006015 Start Date*: 2006-11-27
    Sponsor Name:South Tees Acute Hospitals NHS Trust
    Full Title: Effects of the Modification of the Daily Flow Rate with a Constant Daily Dose on Patient's Reported Analgesia in Intathecal Therapy
    Medical condition: Chronic Pain.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10049475 Chronic pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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: 2010-020087-38 Sponsor Protocol Number: 2.8022010 Start Date*: 2010-11-25
    Sponsor Name:South Tees Hospitals NHS Foundation Trust
    Full Title: Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patient Global Perceived Effect in Intrathecal Therapy for Pain.
    Medical condition: Severe, chronic pain in patients who require intrathecal analgesia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10049475 Chronic Pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    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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