Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Botanical drug

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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    8 result(s) found for: Botanical drug. Displaying page 1 of 1.
    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: 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: 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: 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: 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: 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: 2008-005112-41 Sponsor Protocol Number: SRT-501-012 Start Date*: 2009-04-17
    Sponsor Name:Sirtris Pharmaceuticals Inc.
    Full Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma
    Medical condition: Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028228 Multiple myeloma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) 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)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Jun 07 08:41:42 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA