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    Summary
    EudraCT Number:2015-004904-50
    Sponsor's Protocol Code Number:GWEP15100
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-04
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-004904-50
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of Cannabidiol (GWP42003-P) in infants with Infantile Spasms following an initial open label pilot study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms
    A.4.1Sponsor's protocol code numberGWEP15100
    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
    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 INNCannabidiol
    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.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
    Infantile Spasms
    E.1.1.1Medical condition in easily understood language
    Spasms in infants
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10021750
    E.1.2Term Infantile spasms
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Pilot Phase:
    •To determine the maximum safe, tolerable dose and dosing regimen of GWP42003-P in infants with IS, to be utilized in the pivotal phase and open-label extension (OLE).
    •To assess the number and proportion of patients considered treatment responders, defined as those free of spasms and have resolution of hypsarrhythmia at the end of the 2-week treatment period.
    Pivotal Phase:
    •To assess the number and proportion of patients considered treatment responders, defined as those free of spasms and have resolution of hypsarrhythmia, at the end of the 2-week blinded treatment period versus placebo.
    OLE:
    •To assess the long term safety of GWP42003-P in infants with IS.
    E.2.2Secondary objectives of the trial
    All Phases:
    •To assess the number and proportion of patients who are free of clinical spasms at the end of the treatment period •To assess the number and proportion of patients who have resolution of hypsarrhythmia at the end of the treatment period •To assess changes in spasms and seizure subtypes by caregiver observation during the treatment period•To determine time to cessation of spasms during the treatment period.
    Pivotal Phase Only
    •To assess the safety and tolerability of GWP42003-P.
    •To determine the population pharmacokinetics (POPPK) of CBD and its metabolites.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the trial, patients must fulfil ALL of the following criteria:
    •Patient’s parent(s)/legal representative is willing and able to give informed consent for the patient’s participation in the trial.
    •Patient and their caregiver are willing and able (in the investigator’s opinion) to comply with all trial requirements.
    •Patient is diagnosed with IS
    •Patient has failed to respond adequately following treatment with 1 or more approved IS therapies
    •Patient’s parent(s)/legal representative is willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
    •Patient’s parent(s)/legal representative is willing to allow the patient’s primary care practitioner (if they have one) and consultant (if they have one) to be notified of participation in the trial, if the primary care practitioner/consultant is different to the investigator.
    •All non-pharmacological interventions for epilepsy must have been stable for 2 weeks prior to screening.
    E.4Principal exclusion criteria
    The patient may not enter the trial if ANY of the following apply:
    •Patient is currently taking or has taken clobazam or any oral mammalian target of rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit.
    •Patient has a QT interval, corrected for heart rate with Bazett’s formula (QTcB), of > 460 msec on ECG.
    •Patient’s caregiver is currently giving or has given recreational or medicinal cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the screening visit, as determined by investigator interview with patient’s caregiver.
    •Patient’s caregiver is unwilling to abstain from giving the patient (including the patient’s mother abstaining themselves, if breastfeeding) recreational or medicinal cannabis, or synthetic cannabinoid-based medications (other than the study IMP), during the trial, as determined by investigator interview with patient’s caregiver.
    •Patient has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s), such as sesame oil.
    •Patient has significantly impaired hepatic function at the screening visit.
    •Patient has received an IMP as part of a clinical trial within a minimum of 5 half-lives prior to the screening visit.
    •Patient has 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 trial, may influence the result of the trial, or may affect the patient’s ability to take part in the trial.
    •Any abnormalities identified following a physical examination of the patient that, in the opinion of the investigator, would jeopardize the safety of the patient or confound assessment of efficacy if they took part in the trial.
    •Patient has been previously included in the pilot or pivotal phase of this trial.
    •Patient has travel outside the country and/or United States state of residence planned during the trial, unless the patient has confirmation that the IMP is permitted in the destination country/state.
    E.5 End points
    E.5.1Primary end point(s)
    Pilot Phase:
    •To assess the safety as determined by AEs, clinical laboratory tests, ECG, vital signs and physical examinations during the treatment period.
    •To assess the number and proportion of patients who are free of spasms and have resolution of hypsarrhythmia at the end of the 2-week treatment period
    Pivotal Phase:
    •The number and proportion of patients who are free of spasms and have resolution of hypsarrhythmia at the end of the 2- week treatment period.
    OLE:
    •To assess the long term safety as determined by AEs, clinical laboratory tests, ECG, vital signs and physical examinations during the treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pilot Phase: At visits 2, 3 and 4
    Pivotal Phase: At visit 4
    Open Label Extension Phase: At visits 4 to safety follow up
    E.5.2Secondary end point(s)
    All Phases:
    •The number and proportion of patients who are free of clinical spasms at the end of the treatment period.
    •The number and proportion of patients who have resolution of hypsarrhythmia at the end of the treatment period.
    Pivotal Phase Only:
    •Safety and tolerability as determined by AEs, clinical laboratory tests, ECG, physical examinations and vital signs.
    •Measurement, where possible, of plasma concentrations of CBD and its metabolites will be investigated using a sparse sampling approach, with the aim to define a POPPK model.
    OLE Only:
    •The number and proportion of patients who are free of spasms and have resolution of hypsarrhythmia after 3, 6, 9 and 12 months treatment.
    •Number and proportion of patients with relapse of spasms, and the time to relapse, as determined by caregiver diaries.



    E.5.2.1Timepoint(s) of evaluation of this end point
    Pilot Phase: At visits 2, 3 and 4
    Pivotal Phase: At visits 2, 3 and 4
    Open Label Extension Phase: At visits 4 to safety follow up
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Hungary
    Italy
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 202
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 202
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 No
    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
    Paediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 202
    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
    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 Decision2017-04-05
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-13
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