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    Summary
    EudraCT Number:2013-000212-22
    Sponsor's Protocol Code Number:GWAP1241
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-30
    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 number2013-000212-22
    A.3Full title of the trial
    A double-blind, randomised, placebo-controlled, parallel group study of GWP42003 as adjunctive therapy in the first line treatment of schizophrenia or related psychotic disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GWP42003 as adjunctive therapy to first line antipsychotics in schizophrenia and related psychotic disorders
    A.4.1Sponsor's protocol code numberGWAP1241
    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 Research 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 Research Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Research Ltd
    B.5.2Functional name of contact pointGW Research 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 nameCannabidiol (CBD)
    D.3.2Product code GWP42003
    D.3.4Pharmaceutical form Oral solution
    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.3.8INN - Proposed INNNot applicable
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeGWP42003
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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 placeboOral solution
    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
    Schizophrenia or related psychotic disorder
    E.1.1.1Medical condition in easily understood language
    Schizophrenia or related psychotic disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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 GWP42003 as an adjunctive therapy to first line treatment in alleviating symptoms of schizophrenia or related psychotic disorder (as measured by the PANSS Total score).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of GWP42003 compared with placebo on:
    -Responder analysis of the overall symptom severity of articipants with schizophrenia or related psychotic disorder (as asessed by PANSS Total score)
    -PANSS Positive ‘P’, PANSS Negative ‘N’ and PANSS General ‘G’ scores
    -Scale for the ssessment of Negative Symptoms (SANS) questionnaire score
    -Clinical assessment of the (change in) mental state
    -Participant’s quality of life
    -Extrapyramidal symptoms
    -Cognition
    -Functioning and sleep
    -Change in dependence disorder(s)
    -Body weight, waist measurement and BMI
    -HDL-cholesterol levels
    -LFTs & hormonal marker serum prolactin
    -Markers of inflammation
    -Cannabinoid plasma levels
    -To explore the relationship between the change in PANSS Total, PANSS 'P', 'N' & 'G' & SANS scores and plasma levels of GWP42003.
    -To assess the safety & tolerability of GWP42003 as adjunctive therapy to existing first line treatments on:
     AE
     Clinical laboratory tests
     Vital signs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant is willing and able to give written informed consent for participation in the study and does not require involuntary treatment.
    -Male or female participant(s) aged 18 to 65 years.
    -Participant is able (in the investigator’s opinion) and willing to comply with all study requirements.
    -Participant is diagnosed with schizophrenia or a related psychotic disorder (such as schizoaffective or schizophreniform disorder) as defined by the Diagnostic and Statistical Manual of Mental Disorders Version 4.
    -Participant must have been treated for a minimum of four-weeks and be on a stable dose of their current AP medication.
    -Participant must have shown the capacity to respond at least partially to first line AP medication in the opinion of the investigator.
    -Participant must be able to remain stable on their dose of AP and concomitant medications for the duration of the study, in the opinion of the investigator.
    -Participant is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
    -Participant is 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
    -Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Products (IMPs).
    -Participant has a PANSS Total score of < 60 at Visit 1.
    -Participant presents with a current clinical picture and/or history that is consistent with:
    delirium or dementia
    acute drug induced psychosis
    bipolar disorder
    -Participant is taking more the one AP medication during the study.
    -Female participants of child bearing potential and male participants whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however a male condom should not be used in conjunction with a female condom).
    -Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
    -Participants who have received an IMP within 30 days prior to the screening visit.
    -Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
    -Following a physical examination, the participant has any abnormalities that, in the opinion of the investigator would prevent the participant from safe participation in the study.
    -Unwilling to abstain from donation of blood during the study.
    -Travel outside the country of residence planned during the study.
    -Participants previously randomised into this study.
    E.5 End points
    E.5.1Primary end point(s)
    PANSS Total score. The variable for analysis will be the change in mean PANSS Total score from baseline to the end of the treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed at: Visit 1 (Day 1); Visit 2 (Day 8); Visit 3 (Day 22) and Visit 4 (Day 43)
    E.5.2Secondary end point(s)
    The efficacy of GWP42003 will also be evaluated through the following instruments and measures:
    -Responder analysis of PANSS Total score
    -PANSS ‘P’
    -PANSS ‘N’
    -PANSS ‘G’
    -SANS
    -CGI-S and CGI-I
    -GAF
    -SAS
    -BACS
    -PGIC of functioning and sleep
    -CGIC of functioning and sleep (if applicable)
    -Dependence disorder questionnaire (if applicable)
    -Body weight, waist measurement and BMI
    -HDL-cholesterol levels
    -LFTs and hormonal marker serum prolactin
    -Markers of inflammation including cytokines IL-2, IL-6 and IFNγ and CRP
    -Cannabinoid plasma levels
    PANSS scores (Total, ‘G’, ‘P’, ‘N’ scores) and SANS will be correlated with plasma GWP42003 levels at end of week 3 (Visit 3) and end of treatment (Visit 4).

    Safety and tolerability of GWP42003 as adjunctive therapy to existing first line treatments on:
    • AEs
    • Clinical laboratory tests
    • Vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessed at: Visit 1 (Day 1); Visit 2 (Day 8); Visit 3 (Day 22) & Visit 4 (Day 43)
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 months4
    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 months4
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 78
    F.1.3Elderly (>=65 years) No
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 78
    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 Decision2013-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-08
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