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    EudraCT Number:2014-002594-11
    Sponsor's Protocol Code Number:GWEP1330
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-002594-11
    A.3Full title of the trial
    A double blind, randomized, placebo-controlled, two-part study to investigate the pharmacokinetics, followed by efficacy and safety of GWP42006 as add-on therapy in patients with inadequately controlled focal seizures.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of GWP42006 in people with focal seizures
    A.4.1Sponsor's protocol code numberGWEP1330
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02369471
    A.5.4Other Identifiers
    Name:US NCT NumberNumber:NCT02365610
    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+441223266800
    B.5.5Fax number+441223235667
    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 nameGWP42006 Oral Solution
    D.3.2Product code GWP42006
    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.3.9.2Current sponsor codeGWP42006
    D.3.9.3Other descriptive nameGWP42006
    D.3.9.4EV Substance CodeSUB123082
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E.1.1.1Medical condition in easily understood language
    Focal Seizures
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10016843
    E.1.2Term Focal seizures
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    To determine the pharmacokinetics (PK) of GWP42006 and human metabolites, 7-hydroxy- cannabidivarin (7-OH-CBDV) and 6-hydroxy- cannabidivarin (6-OH-CBDV), in the presence of other antiepileptic drugs (AEDs).
    Part B:
    To evaluate the efficacy of GWP42006, compared with placebo, as add-on therapy to treat inadequately controlled focal seizures.
    E.2.2Secondary objectives of the trial
    Part A:
    • To evaluate the safety and tolerability of GWP42006 compared with placebo, in the presence of other AEDs.
    • To evaluate effects of GWP42006 on plasma concentrations of concomitant AEDs.
    Part B:
    • To evaluate the effect of GWP42006 compared with placebo on other efficacy measures.
    • To evaluate the safety and tolerability of GWP42006 compared with placebo.
    • To evaluate the effect of GWP42006 on health utilization compared with placebo.
    • To evaluate the effects of GWP42006 on cognitive function.
    • To determine plasma concentrations of GWP42006 and main metabolites following multiple doses of GWP42006.
    • To evaluate effects of GWP42006 on plasma concentrations of concomitant AEDs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient must be willing and able to give informed consent for participation in the study.
    • Male or female aged between 18 and 65 years, inclusive.
    • Well-documented history of focal epilepsy, with focal seizures as the primary seizure type, compatible electroencephalogram and clinical history.
    • Documented CT/MRI that shows no progressive neurologic abnormality.
    • Has focal seizures despite prior treatment with at least two AEDs (whether as monotherapies or in combination).
    • Patient is willing to keep any factors expected to affect seizures stable (such as the level of alcohol consumption and smoking).
    • Patient is able (in the investigators opinion) and willing to comply with all study requirements (including accurate diary completion).
    • Patient is willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.

    Part A only
    • Currently treated with one to three AEDs as follows:
    Group 1 - including Carbamazepine, Phenobarbital, Primidone or Phenytoin and excluding Valproic Acid (VPA).
    Group 2 - including VPA and excluding Carbamazepine, Phenobarbital, Primidone and Phenytoin.
    Group 3 - excluding VPA, Carbamazepine, Phenobarbital, Primidone and Phenytoin.
    • All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for two weeks prior to screening and the patient is willing to maintain a stable regimen throughout the study.

    Part B only
    • Currently treated with one to three AEDs.
    • All medications or interventions for epilepsy (including ketogenic diet) must have been stable for one month prior to screening and the patient is willing to maintain a stable regimen throughout the study.
    • At the end of the baseline period patients must also meet the following criteria:
    Complied with diary completion, having no more than three missed diary entries during baseline.
    E.4Principal exclusion criteria
    • Time of onset of epilepsy treatment is less than two years prior to enrolment.
    • Episode(s) of status epilepticus during one year prior to screening.
    • History of pseudo-seizures.
    • Patient has clinically significant unstable medical conditions other than epilepsy.
    • Patient has an illness in the four weeks prior to screening or randomization, other than epilepsy, which in the opinion of the investigator would affect seizure frequency.
    • Patient has, in the investigator’s opinion, clinically significantly abnormal laboratory values.
    • Patient has impaired hepatic function at Visit 1 defined as the following: ALT >3 x ULN or AST >3 x ULN or TBL > ULN.
    • In the opinion of the investigator the patient has clinically significant abnormalities in the 12-lead electrocardiogram (ECG) measured at screening or randomization or any concurrent cardiovascular conditions, which will interfere with the ability to read their ECGs.
    • Active suicidal plan/intent in the past six months, or a history of suicide attempt in the last two years, or more than one lifetime suicide attempt.
    • Patient has a history or presence of alcohol or substance abuse within the two years prior to screening 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 cannabinoid based medications within the three months prior to screening and is unwilling to abstain for the duration for the study.
    • Patient has taken St John’s Wort in the two weeks prior to screening and/or is unwilling to abstain throughout the study.
    • Any known or suspected hypersensitivity to cannabinoids, sesame oil or any of the excipients of the IMP(s).
    • Female patients of child bearing potential and male patients whose partner is of child bearing potential, unless willing to ensure that they and/or their partner use a highly effective method of contraception.
    • Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
    • Patients who have received an IMP within the 12 weeks prior to the screening visit.
    • 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 the patient’s ability to participate in the study.
    • 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.
    • Unwilling to abstain from donation of blood during the study.
    • Travel outside the country of residence planned during the study.
    • Patients previously randomized into this study.
    • Patient has consumed grapefruit or grapefruit juice three days prior to randomization and/or unwilling to abstain in the three days prior to PK sampling visits.

    Part B only
    • Vagus Nerve Stimulation, Deep Brain Stimulation, Responsive Neurostimulator System or other epilepsy neurostimulation device have been implanted or activated less than one year prior to screening, and/or stimulation parameters have been stable for less than one month, and/or battery life of unit not anticipated to extend for duration of trial.
    E.5 End points
    E.5.1Primary end point(s)
    Part A - Primary endpoint is the plasma concentrations of GWP42006, 7-OH-CBDV and 6-OH-CBDV with the aim of defining Cmax, Cmin, tmax, AUC0-t, AUC0-inf, and t1/2.

    Part B - Primary endpoint is the mean percentage change from baseline to the end of treatment in focal seizure frequency in patients taking GWP42006 compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A:
    •Visit A2 - pre-IMP-dose and 30min, 1h, 2h, 4h and 8h after IMP dose.
    •Visit A4 - pre-IMP-dose and 30min, 1h, 2h, 4h and 8h after IMP dose.
    •Visit A5 - 24 +/- 6h after last IMP dose.
    •Visit A6 - 72 +/- 24h after last IMP dose.
    Part B:
    •Baseline (Visit B1 to B2) and last 28 days of the evaluable period
    E.5.2Secondary end point(s)
    The secondary endpoints for Part A are:
    • Safety and tolerability (adverse events [AEs], clinical laboratory testing, vital signs)
    • Plasma concentrations of concomitant AEDs.

    For Part B, efficacy safety and other endpoints are as follows:
    Efficacy endpoints:

    • Number of patients considered treatment responders defined as those with a ≥25%, ≥50%, ≥75% and 100% reduction in focal seizure frequency.
    • Proportion of patients with a 0-24%, ≥25-50%, ≥50%-74% and ≥75%-100% reduction in focal seizure frequency.
    • Change in seizure subtypes frequency.
    • Change in composite seizure score.
    • Change in number of focal seizure free days.
    • Change in use of rescue medication.
    • Subject Global Impression of Change (SGIC).
    • Physician Global Impression of Change (PGIC).

    Safety and tolerability endpoints:
    • AEs.
    • Clinical laboratory testing.
    • Vital signs.
    • Columbia Suicide Severity Rating Scale (C-SSRS).
    • Cannabis Withdrawal Scale (CWS) score.
    • Abuse liability.

    Other endpoints:
    • Change in number of inpatient hospitalizations or out of visit contact with medical staff due to epilepsy.
    • Cognitive assessment scores.
    • Plasma concentrations of GWP42006 and main metabolites.
    • Plasma concentrations of concomitant AEDs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A:
    •Safety and tolerability - Visit A1 to visit A7
    •AEDs - Visits A2 (baseline) and A4
    Part B:
    •Safety and tolerability - Visit B1 to visit B9
    •Efficacy - Baseline (Visit B1 to B2) and last 28 days of the evaluable period; Visit B7 for PGIC and SGIC.
    •Other endpoints - Visits B2 (baseline) and B7; Visit B5 and B7 for plasma concentrations of GWP42006 and metabolites.
    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 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. 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 trial8
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 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
    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 years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days14
    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: 166
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    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 GWP42006 in this population 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 Decision2015-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-01
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