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Clinical trials for sativex

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   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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    41 result(s) found for: sativex. Displaying page 2 of 3.
    EudraCT Number: 2012-003771-18 Sponsor Protocol Number: GWSP08258 Start Date*: 2013-08-06
    Sponsor Name:GW Pharma Ltd.
    Full Title: The efficacy, safety and tolerability of Sativex as an adjunctive treatment to existing anti-spasticity medications in children aged 8 to 18 years with spasticity due to cerebral palsy or traumatic...
    Medical condition: Spasticity due to cerebral palsy (CP) or traumatic central nervous system injury.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) CZ (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: 2015-004451-40 Sponsor Protocol Number: H15/02 Start Date*: 2016-02-17
    Sponsor Name:Almirall Hermal GmbH
    Full Title: SATIVEX® AS ADD-ON THERAPY VS. FURTHER OPTIMIZED FIRST-LINE ANTISPASTICS THE S A V A N T TRIAL
    Medical condition: Moderate to severe spasticity due to MS (multiple sclerosis).
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004852 10052785 Multiple sclerosis acute and progressive HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004378-92 Sponsor Protocol Number: EdomTHC Start Date*: 2019-05-27
    Sponsor Name:Fundació Clínic per la Recerca Biomèdica
    Full Title: Effect of cannabinoids (THC / CBD) on hyperalgesia in patients with deep endometriosis
    Medical condition: Deep endometriosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038604 - Reproductive system and breast disorders 10014778 Endometriosis PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002786-35 Sponsor Protocol Number: CUA1 Start Date*: 2020-06-25
    Sponsor Name:Charlotte Uggerhøj Andersen
    Full Title: Pharmacokinetics and side effects for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease and patients on dialysis.
    Medical condition: Chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    23.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2012-005328-14 Sponsor Protocol Number: SATIVEX-2013 Start Date*: 2013-04-16
    Sponsor Name:Spinal Cord Injury Centre of Western Denmark
    Full Title: Effect of Sativex on neuropathic pain and spasticity following spinal cord injury
    Medical condition: Neuropathic pain and spasticity following spinal cord injury
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004852 10054095 Neuropathic pain LLT
    14.1 100000004852 10041416 Spasticity LLT
    14.1 10022117 - Injury, poisoning and procedural complications 10041552 Spinal cord injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001056-17 Sponsor Protocol Number: 3606 Start Date*: 2020-08-14
    Sponsor Name:Kings's College London [...]
    1. Kings's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia.
    Medical condition: Clinically significant agitation in Alzheimer's Diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2022-001777-31 Sponsor Protocol Number: IG2021370 Start Date*: 2023-05-08
    Sponsor Name:Hospital de Neurorrehabilitación Institut Guttmann
    Full Title: Pilot study on the effect of cannabinoids THC + CBD on resistant spasticity in patients with chronic spinal cord injury.
    Medical condition: Pilot study on the effect of THC+CBD cannabinoids on resistant spasticity in patients with chronic spinal cord injury.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002258-30 Sponsor Protocol Number: M/SATIVX/01 Start Date*: 2011-10-04
    Sponsor Name:ALMIRALL PRODESFARMA
    Full Title: NEUROPHYSIOLOGIC STUDY AIMED AT EVALUATING ON EFFECT OF SATIVEX® ON SPASTICITY IN PROGRESSIVE MULTIPLE SCLEROSIS
    Medical condition: Subject of both male and female gender affected by Secondary-Progressive (SP) or Primary-Progressive (PP) MS
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000393-47 Sponsor Protocol Number: SP000680 Start Date*: 2004-09-22
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: Effect of Cannabis Based Medicine Extract Sativex on brain function as assessed by fMRI and neurophysiologic evaluation in patients with Multiple Sclerosis a double blind, randomised, placebo-co...
    Medical condition: Treatment of spasticity in patients with Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028245 Multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001739-21 Sponsor Protocol Number: FiDoAp Start Date*: 2012-03-26
    Sponsor Name:ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
    Full Title: A study of Sativex for pain Relief and appetite stimulation in Patients with advanced malignancy. Phase II
    Medical condition: advanced malignant cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022808-40 Sponsor Protocol Number: CANALS Start Date*: 2011-01-13
    Sponsor Name:FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
    Full Title: A fase II, randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients
    Medical condition: amyotrophic lateral sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10002026 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    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 (Completed) 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 (Completed) GB (GB - no longer in EU/EEA) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2010-024227-24 Sponsor Protocol Number: SAT-HD Start Date*: 2011-04-05
    Sponsor Name:Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
    Full Title: Ensayo clínico en fase II sobre neuroprotección por cannabinoides en enfermedad de Huntington
    Medical condition: Enfermedad de Huntington
    Disease: Version SOC Term Classification Code Term Level
    13 10070668 Enfermedad de Huntington LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    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: 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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-007690-21 Sponsor Protocol Number: 42160443PAI2001 Start Date*: 2009-10-02
    Sponsor Name:Janssen Cilag International NV
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Foll...
    Medical condition: Subjects with inadequately controlled, moderate to severe, chronic, cancer-related pain
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058019 Cancer pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Completed) PT (Completed) IT (Completed) NL (Prematurely Ended)
    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
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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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