Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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   43871   clinical trials with a EudraCT protocol, of which   7290   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
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-000180-28
    Sponsor's Protocol Code Number:GWMD09126
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-04-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-000180-28
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled parallel group, pilot study of 40:1 ratio of formulated GWP42003 : GWP42004 in the treatment of iatrogenic weight gain and dyslipidaemia associated with olanzapine or other antipsychotic(s) treatment in subjects with schizophrenia or other non-affective psychosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GWMD09126 - GWP42003:GWP42004 antipsychotic(s) weight gain treatment
    A.4.1Sponsor's protocol code numberGWMD09126
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGW Pharma Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGW Pharma Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Pharma Ltd.
    B.5.2Functional name of contact pointGW Pharma Ltd. Switchboard
    B.5.3 Address:
    B.5.3.1Street AddressPorton Down Science Park
    B.5.3.2Town/ citySalisbury, Wiltshire
    B.5.3.3Post codeSP4 0JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441980557000
    B.5.5Fax number+441980557111
    B.5.6E-mailinfo@gwpharm.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGWP42003 Capsule
    D.3.2Product code EN0012
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGWP42003
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePurified extract of botanical origin
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGWP42004 Capsule
    D.3.2Product code EN0011
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGWP42004
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePurified extract of botanical origin
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Iatrogenic weight gain and dyslipidaemia associated with treatment using antipsychotic medication
    E.1.1.1Medical condition in easily understood language
    Weight gain; high blood cholesterol and triglycerides associated with treatment using antipsychotic medication
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10058110
    E.1.2Term Dyslipidemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10047896
    E.1.2Term Weight gain
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a 40:1 ratio of GWP42003 : GWP42004 compared with placebo in the change in body weight from baseline in subjects treated with olanzapine or other antipsychotic(s) in subjects with schizophrenia or other non-affective psychosis.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of a 40:1 ratio of GWP42003 : GWP42004 compared with placebo on:
    Lipid parameters; Glucose Control (fasted); Insulin Control (fasted); Glycosylated haemoglobin A1c (HbA1c); Adipose tissue distribution; Markers of adipocyte function including leptin and adiponectin; Markers of inflammation including cytokines and C-Reactive Protein (CRP); Hormonal markers including prolactin; Endocannabinoid plasma levels; Positive symptoms of schizophrenia; Negative symptoms of schizophrenia; General symptoms of schizophrenia; Physician’s global impression of illness severity; Subject’s quality of life; Assessment of symptoms of depression; Assessment of extrapyramidal symptoms; Assessment of mood; Assessment of appetite.
    To assess the safety and tolerability of a 40:1 ratio of GWP42003 : GWP42004 compared with placebo on:
    Adverse events (AE); Vital Signs; Electrocardiogram (ECG); Laboratory findings; Physical examination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study subjects must fulfil ALL of the following criteria:
    - Willing and able to give informed consent for participation in the study.
    - Subject is aged 18 years or above.
    - Diagnosis (DSM-IV-TR) of schizophrenia, or other non-affective psychosis.
    - Receiving at least one antipsychotic.
    - The dose of antipsychotic(s) is stable for at least 2 weeks prior to randomisation (Visit 2).
    - Subject is willing to maintain a stable dose of antipsychotic(s) for the duration of the study.
    - Evidence of recent weight gain attributable to antipsychotic treatment (in the opinion of the Investigator), prior to screening (Visit 1). Wherever possible, investigator must exclude other possible causes of weight gain, such as change in exercise, diet , concomitant medications or other illnesses.
    - Each subject must have a further documented 2% weight gain attributable to antipsychotic treatment in the baseline period (between Visits 1 and 2).
    - Willing to maintain a stable dose of any concomitant medications (excluding PRN medicines at the Investigator’s discretion), and have been on a stable dose for a minimum of 6 weeks prior to screening (Visit 1) (with the exception of antipsychotic(s)).
    - No changes in diet or exercise for 6 weeks prior to screening (Visit 1) and subject agrees to maintain stability, for the duration of the study (in the opinion of the investigator).
    - Capable of complying with the study requirements and completing the study (in the opinion of the investigator).
    -Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
    E.4Principal exclusion criteria
    The subject may not enter the study if ANY of the following apply:
    - Subject has Axis I (DSM-IV-TR) diagnosis of schizoaffective disorder.
    - Subject has drug induced or toxic psychosis (in the opinion of the investigator).
    - Subject presents with a clinical picture and/or history that is consistent with:
    - Delirium, dementia, amnesia or other cognitive disorder.
    - Bipolar disorder or major depression.
    - Subject has a significant history of anxiety, suicidal ideation or self-harm based on history or routine psychiatric status examination (in the opinion of the investigator).
    - Subject has an unstable thyroid pathology (including hypo or hyperthyroidism), within the past six months (in the opinion of the investigator).
    - Subject has a history of neuroleptic malignant syndrome.
    - Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2 month period prior to randomisation (Visit 2).
    - Subject has a clinical diagnosis of diabetes.
    - Any known or suspected history of (in the opinion of the investigator):
    - Alcohol or substance abuse;
    - Epilepsy or recurrent seizures.
    - Any known or suspected history of depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression - in the opinion of the investigator).
    - BDI Score ≥ 19 (at Visit 1 or 2).
    - Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator.
    - Genetic dyslipidaemic condition in the opinion of the investigator.
    - Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for 3 months from the date of last dose.
    - Female subjects of child bearing potential, unless willing to use two forms of contraception, one of which must be a barrier contraception (e.g. Female condom of occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months from the date of last dose (however a male condom should not be used in conjunction with the female condom).
    - Male subjects whose partner is of child bearing potential, unless willing to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (e.g. occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months from date of last dose (however a male condom should not be used in conjunction with a female condom).
    - Received an Investigational Medicinal Product within the 90 days before the screening visit (Visit 1).
    - In the opinion of the investigator, is not considered to be suitable for the study.
    - Poor compliance as observed during screening period.
    - Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, influence the result of the study, or the subject's ability to participate in the study.
    - Any abnormalities identified during the physical examination at Visit 1 that in the opinion of the investigator would prevent the subject from safe participation in the study.
    - Unwilling to abstain from donation of blood during the study.
    - Previously randomised into this study.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of a 40:1 ratio of GWP42003 : GWP42004 compared with placebo in the change in body weight from baseline in subjects treated with antipsychotic(s) for schizophrenia or other non-affective psychosis
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks post treatment
    E.5.2Secondary end point(s)
    To evaluate the effect of a 40:1 ratio of GWP42003 : GWP42004 compared with placebo on:

    Body Fat Parameters:
    - Change from baseline to end of treatment in skin fold thickness measurements;
    - Change from baseline to end of treatment in waist to hip ratio;

    Lipid Parameters:
    - Change from baseline to end of treatment in serum Total Cholesterol;
    - Change from baseline to end of treatment in serum LDL Cholesterol;
    - Change from baseline to end of treatment in serum HDL Cholesterol;
    - Change from baseline to end of treatment in serum HDL / LDL Cholesterol ratio;
    - Change from baseline to end of treatment in serum HDL / Total Cholesterol ratio;
    - Change from baseline to end of treatment in serum Triglycerides;
    - Change from baseline to end of treatment in serum apolipoprotein markers (ApoA & ApoB);
    - Change from baseline to end of treatment in serum Apo A/Apo B ratio;
    - Change from baseline to end of treatment in serum non-esterified (“free”) fatty acids to the end of treatment;

    Glucose Control:
    - Change from baseline to end of treatment in glucose control parameters (fasting plasma glucose);
    - Change from baseline to end of treatment in HbA1c (whole blood);

    Insulin Control:
    - Change from baseline to end of treatment in insulin control parameters (fasting serum insulin);

    Psychiatric/Clinical Assessments:
    Change from baseline to end of treatment in the following assessments:
    - Positive and Negative Syndrome Scale (PANSS) ‘P’; ‘N’; ‘G’;
    - Global Assessment of Functioning (GAF);
    - Beck Depression Inventory (BDI);
    - UWIST Mood Adjective Checklist (UMACL);
    - Simpson-Angus Scale (SAS);
    - End of treatment assessment of Clinician’s Global Impression of Change (CGIC);

    Hormonal Marker:
    - Change from baseline to end of treatment in serum prolactin concentration;

    Markers of Inflammation:
    - Change from baseline to end of treatment in serum CRP and serum cytokines (including TNF-α, IL-6 and IL-2);

    Markers of adipocyte function:
    - Change from baseline to end of treatment in serum leptin and adiponectin concentrations;

    Endocannabinoid Levels- where facilities allow:
    - Change from baseline in endocannabinoid plasma levels to the end of treatment;

    Appetite Assessments:
    - Change from baseline in mean appetite NRS score (taken from the last 7 days of baseline period (days -7 to 0) to the end of treatment (taken from last 7 days of treatment period);

    Safety Endpoints:
    To assess the safety and tolerability of a 40:1 ratio of CBD : THCV compared with placebo on:
    - AEs;
    - Vital signs;
    - ECG;
    - Laboratory findings;
    - Physical examination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 weeks post treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Pilot Study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal standard of care will resume as clinical evidence of the efficacy of these medicines in this population of participants has yet to be determined.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-10-01
    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-Mon May 06 03:42:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA