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Clinical trials for Nabiximols

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    11 result(s) found for: Nabiximols. Displaying page 1 of 1.
    EudraCT Number: 2020-004306-58 Sponsor Protocol Number: GWSP20104 Start Date*: 2022-01-28
    Sponsor Name:GW Pharma Limited
    Full Title: A randomized double-blind placebo-controlled study of nabiximols in patients with spasticity in multiple sclerosis
    Medical condition: Symptomatic treatment of spasticity in patients with MS
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003271-18 Sponsor Protocol Number: GWSP20105 Start Date*: 2021-06-07
    Sponsor Name:GW Pharma Limited
    Full Title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis
    Medical condition: Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Ongoing) ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-002625-29 Sponsor Protocol Number: GWSP19066 Start Date*: 2020-01-14
    Sponsor Name:GW Pharma Limited
    Full Title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis
    Medical condition: Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Ongoing) GB (GB - no longer in EU/EEA) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2019-002623-14 Sponsor Protocol Number: GWSP18023 Start Date*: 2020-03-17
    Sponsor Name:GW Pharma Ltd
    Full Title: A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients with Spasticity Due to Multiple Sclerosis
    Medical condition: Symptomatic relief of spasticity in Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) GB (GB - no longer in EU/EEA) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2016-000564-42 Sponsor Protocol Number: CANNA-TICS Start Date*: 2017-06-14
    Sponsor Name:Hannover Medical School
    Full Title: A randomized multi-centre double-blind placebo controlled trial to demonstrate the efficacy and safety of nabiximols in the treatment of adults with chronic tic disorders (CANNA-TICS)
    Medical condition: Chronic tic disorders and Tourette syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10043835 Tic disorders HLT
    20.0 100000004850 10018269 Gilles de la Tourette syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016529-32 Sponsor Protocol Number: GWCA0999 Start Date*: 2010-04-02
    Sponsor Name:GW Pharma Ltd
    Full Title: A multicenter, non-comparative, open-label extension study to assess the long term safety of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in patients with uncontrolled pers...
    Medical condition: Pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) CZ (Completed) HU (Completed) DE (Completed) PL (Completed) LT (Completed) LV (Completed) EE (Prematurely Ended) BG (Completed) ES (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-000840-32 Sponsor Protocol Number: CUEBS_2016 Start Date*: 2016-06-24
    Sponsor Name:FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    Full Title: Clinical and Urodynamic Evaluation of Bladder dysfunction in multiple sclerosis patients treated with Sativex
    Medical condition: Multiple Sclerosis patients treated with nabiximols (Sativex¿, Almirall)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    20.1 10029205 - Nervous system disorders 10039720 Sclerosis multiple LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-016065-29 Sponsor Protocol Number: GWCA0962 Start Date*: 2010-03-10
    Sponsor Name:GW Pharma Ltd.
    Full Title: A double blind, randomized, placebo-controlled, parallel group study of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in pa...
    Medical condition: Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) DE (Completed) PL (Completed) BG (Completed) HU (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2010-022905-17 Sponsor Protocol Number: GWCA1103 Start Date*: 2011-12-26
    Sponsor Name:GW Pharma Ltd.
    Full Title: A two-part, placebo-controlled, study of the safety and efficacy of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in patien...
    Medical condition: Pain in patients with advanced cancer who have inadequate analgesia even with optimized chronic opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) GB (Completed) LT (Completed) PL (Completed) DE (Completed) HU (Completed) RO (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-016064-36 Sponsor Protocol Number: GWCA0958 Start Date*: 2010-03-10
    Sponsor Name:GW Pharma Ltd.
    Full Title: A double blind, randomized, placebo-controlled, parallel group study of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in p...
    Medical condition: Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) BE (Completed) GB (Completed) DE (Completed) RO (Completed) HU (Completed) EE (Prematurely Ended) LV (Completed) LT (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2018-000100-41 Sponsor Protocol Number: PN018 Start Date*: 2018-11-21
    Sponsor Name:Abide Therapeutics, Inc.
    Full Title: A Randomized, Placebo-Controlled Study of ABX-1431 in Adult Patients with Tourette Syndrome or Chronic Motor Tic Disorder
    Medical condition: Tourette syndrome or chronic motor tic disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10044127 Tourette's syndrome LLT
    20.0 100000004873 10009005 Chronic motor tic disorder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (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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