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    Summary
    EudraCT Number:2014-000995-24
    Sponsor's Protocol Code Number:GWEP1332
    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:2014-07-04
    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 number2014-000995-24
    A.3Full title of the trial
    A double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome
    A.4.1Sponsor's protocol code numberGWEP1332
    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 AddressSovereign House, Vision Park, Chivers Way
    B.5.3.2Town/ cityHiston, Cambridge
    B.5.3.3Post codeCB24 9BZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4401223266800
    B.5.5Fax number+4401223235667
    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-P
    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 INNN/A
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeGWP42003-P
    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 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) 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.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 nameCannabidiol (CBD)
    D.3.2Product code GWP42003-P
    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 INNN/A
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeGWP42003-P
    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 number25
    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
    Dravet Syndrome
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10073677
    E.1.2Term Severe myoclonic epilepsy of infancy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    To evaluate the safety of multiple doses of GWP42003-P compared with placebo with respect to:
    • Incidence, type and severity of adverse events (AEs).
    • Effect on vital signs, physical examination parameters including weight.
    • Effect on 12-lead electrocardiogram (ECG) findings.
    • Effect on laboratory parameters.
    • Changes in seizure frequency.
    Part B:
    • To assess the efficacy of GWP42003-P as an adjunctive antiepileptic treatment compared with placebo, with respect to the percentage change from baseline during the treatment period of the study in convulsive seizure frequency.
    E.2.2Secondary objectives of the trial
    Part A:
    • To determine the pharmacokinetics of CBD and its major metabolites following single and multiple doses of GWP42003-P.
    • To investigate the effect of GWP42003-P on the plasma concentration of clobazam and its primary metabolite, N-CLB, if taken as a concomitant medication.
    • Where possible, to investigate the effects of CBD on plasma concentrations of other concomitant AEDs, if applicable.
    Part B:
    • To assess changes from baseline in non-convulsive seizure frequency, duration of seizures, usage of rescue medication, number of inpatient hospitalizations due to epilepsy, sleep disruption, daytime sleepiness, quality of life, growth and development, menstruation cycles (in females) and conduct behavioral assessments in patients taking GWP42003-P as an adjunctive treatment, when compared with placebo.
    • To determine effects of GWP42003-P on plasma concentrations of concomitant AEDs, where available.
    • To assess the safety of GWP42003-P when compared with placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria: Part A
    For inclusion in Part A of the study, patients must fulfil ALL of the following criteria:
    • Patient and/or parent(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
    • Patient and their caregiver must be willing and able (in the investigator’s opinion) to comply with all study requirements.
    • Patient must be male or female aged between 4 and 10 years (inclusive).
    • Patient must have a documented history of DS which is not completely controlled by current AEDs.
    • Patient must be taking one or more AEDs at a dose which has been stable for at least four weeks.
    • All medications or interventions for epilepsy (including ketogenic diet and VNS) must have been stable for four weeks prior to screening and patient and caregiver are willing to maintain a stable regimen throughout the study.
    • Patient and/or parent(s)/legal representative is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
    Inclusion Criteria: Part B
    For inclusion in Part B of the study, patients must fulfil ALL of the following criteria:
    • Patient and/or parent(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
    • Patient and their caregiver must be willing and able (in the investigator’s opinion) to comply with all study requirements.
    • Patient must be male or female aged between 2 and 18 years (inclusive).
    • Patient must have a documented history of DS which is not completely controlled by current AEDs.
    • Patient must be taking one or more AEDs at a dose which has been stable for at least four weeks.
    • All medications or interventions for epilepsy (including ketogenic diet and VNS) must have been stable for four weeks prior to screening and patient and caregiver are willing to maintain a stable regimen throughout the study.
    • Patient and/or parent(s)/legal representative is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
    E.4Principal exclusion criteria
    Exclusion Criteria: Parts A and B
    The patient may not enter the study (Part A or Part B) if ANY of the following apply:
    • Patient has clinically significant unstable medical conditions other than epilepsy.
    • Patient has had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization, other than epilepsy.
    • Patient has clinically significantly abnormal, in the investigator’s opinion, laboratory values at screening or randomization.
    • Patient has clinically relevant abnormalities in the 12-lead ECG measured at screening or randomization.
    • Patient has any concurrent cardiovascular conditions, which will, in the investigators opinion, interfere with the ability to read their ECGs.
    • Patient has a history or presence of alcohol or substance abuse within the last two years prior to the study or daily consumption of five or more alcohol-containing beverages.
    • Patient is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) within the three months prior to study entry.
    • Patient is unwilling to abstain from using recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex) during the study.
    • Patient has a history of symptoms (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope) related to a drop in blood pressure due to postural changes.
    • Patient has ingested alcohol in the 24 hour period prior to the first study visit and/or is unwilling to abstain from drinking alcohol throughout the treatment period.
    • Patient has consumed grapefruit or grapefruit juice three days prior to screening and/or is unwilling to abstain from consuming these during the study.
    • Patient has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s), e.g., sesame oil.
    • Female patients is of child bearing potential or male patient’s partner is of child bearing potential; unless willing to ensure that they or their partner use highly effective contraception for the duration of the study and for three months thereafter. Highly effective methods of contraception are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include hormonal contraceptives, intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
    • Female patient who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the study and for three months thereafter.
    • Patients who have been part of a clinical trial involving an investigational product in the previous six months.
    • Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient’s ability to participate in the study.
    • Patient has significantly impaired hepatic function at screening (Visit A1 or B1) or randomization(Visit A2 or B2) (Alanine aminotransferase [ALT] >5 x upper limit of normal [ULN] and total bilirubin [TBL] >2 x ULN) OR the ALT or Aspartate aminotransferase (AST) >3 x ULN and TBL >2 x ULN (or international normalized ratio [INR] >1.5).
    • Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study.
    • Patients unwilling to abstain from donation of blood during the study.
    • There are plans for the patient to travel outside their country of residence during the study.
    • Patients previously randomized into this study. In particular, patients randomized in Part A of the study cannot enter Part B.
    • Any history of suicidal behavior or any suicidal ideation of type four or five on the CSSRS at screening.
    •Patient is taking felbamate and they have been taking it for less than one year prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    Part A: The primary endpoint is the safety profile of single and multiple doses of GWP42003-P compared with placebo. The variables for analysis will be the difference in incidence, type and severity of AEs, vital signs, ECG, laboratory, physical examination parameters and changes in seizure frequency of GWP42003-P compared with placebo.
    Part B: The primary endpoint is the mean percentage change from baseline in convulsive seizure frequency during the maintenance period of the study (Day B1 to the end of the evaluable period) in patients taking GWP42003-P compared with placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A

    •Incidence, type and severity of adverse events (AEs) - From Visit A1 to Visit A5
    •Vital signs, ECG, laboratory safety parameters and physical examination parameters - Visits 1, 2, 3 and 4

    Part B
    •Total convulsive seizure frequency - From Visit B1 to Visit B8
    E.5.2Secondary end point(s)
    Part A – Pharmacokinetic:
    1. GWP42003-P: The plasma concentration/time curve of CBD and its major metabolites will be described following single and multiple doses of GWP42003-P, with the aim being to define:
    • Cmax
    • tmax
    • AUC 0-∞, AUC 0-t
    • t½
    2. If taken as a concomitant medication, the plasma concentrations of clobazam and N-CLB will be described pre-treatment and then after 21 days of treatment with GWP42003-P. As far as possible, the plasma concentration/time relationship pre-treatment will be compared with the results following treatment with GWP42003-P. The same analysis will be carried out for other concomitant AEDs, if possible and applicable.
    Part B – Efficacy and Safety:
    1. The following will be analyzed:
    • Number of patients experiencing a 50% or more reduction in convulsive seizures from baseline.
    • Number of patients who are convulsive seizure free.
    • Percentage changes from baseline in non-convulsive seizure frequency.
    • Change in types of seizures.
    • Changes from baseline in duration of seizure subtypes as assessed by the Caregiver Global Impression of Change in Seizure Duration (CGICSD).
    • Changes from baseline in usage of rescue medication.
    • Changes from baseline in number of inpatient hospitalizations due to epilepsy.
    • Changes from baseline in Sleep Disruption 0-10 Numerical Rating Scale (0-10 NRS) score.
    • Changes from baseline in Epworth Daytime Sleepiness Scale (EDSS).
    • Changes from baseline in the Quality of Life in Childhood Epilepsy (QOLCE).
    • Changes from baseline in the Vineland Adaptive Behavior Scales, Second Edition (Vineland-II).
    • Caregiver Global Impression of Change (CGIC).
    2. The safety profile of GWP42003-P will also be the assessed by measuring difference in incidence, type and severity of AEs, Columbia-Suicide Severity Rating Scale (C-SSRS), vital signs, ECG, laboratory, and physical examination parameters of GWP42003-P compared with placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • PK of GWP42003-P and 7-OH-CBD - Visits A2, A4: pre-dose, 2 to 3h post-dose, 4 to 6h post-dose
    • PK of clobazam and N-CLB - A2, A4: 2h post clobazam dose Part B.
    • Percentage change non-convulsive seizure freq : B1-B8
    • Percentage change convulsive seizure freq: B1- B8
    • Treatment responders, Number of status epilepticus episodes
    • Sleep disruption, daytime sleepiness, adaptive behavior - B2 to B6, B8
    • CGIC, CGICSD: B3, B4, B6, B8
    • Change in C-SSRS:B1-B4, B6, B8, B9 and Effect on menstruation:B2, B8
    • Developmental changes in patients < 18 yrs: Height, weight, IGF-1 and Tanner Staging (signs of puberty)
    • Plasma concentrations of AEDs before/after treatment,
    • Incidence, type and severity of AEs: B1 to B9
    • Vital signs, ECG, lab and physical exam parameters - B1to B4, B6, B8
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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 trial6
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Poland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last patient last visit or last contact, whichever occurs last.
    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 months2
    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 months3
    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 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 80
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Some patients entering this study will be unable to give consent personally due to Mental Disability or Cognitive Impairment.
    In these cases consent/assent will be sought from patient and/or parent(s)/legal representative (See 9.1.1 of the Protocol)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 125
    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)
    None
    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 Decision2014-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-26
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