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    Summary
    EudraCT Number:2006-005910-11
    Sponsor's Protocol Code Number:GWSP0604
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-005910-11
    A.3Full title of the trial
    A two-phase Phase 3 study of the safety and efficacy of Sativex®, in the symptomatic relief of spasticity in subjects with spasticity due to multiple sclerosis: Phase A – single blind response assessment; Phase B - double blind, randomised, placebo controlled, parallel group study.
    A.4.1Sponsor's protocol code numberGWSP0604
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name Sativex
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationCanada
    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 nameSativex
    D.3.2Product code GW-1000-02
    D.3.4Pharmaceutical form Oromucosal spray
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1972-08-3
    D.3.9.3Other descriptive namedelta-9-tetrahydrocannabinol
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive nameCannabidiol
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboOromucosal spray
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spasticity in multiple sclerosis (MS)
    MedDRA Classification
    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 GW-1000-02 (named Sativex® in Canada and also named Sativex Oromucosal Spray) compared with placebo in relieving symptoms of spasticity due to multiple sclerosis (MS), in subjects identified as having a capacity to respond to Sativex.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of Sativex compared with placebo on:
    · Secondary measures of spasticity.
    · Functional measures of spasticity.

    To assess the safety and tolerability of Sativex.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria: Screening (i.e. at Visit 1)
    The single blind status of Phase A must be maintained (i.e. subject should not be made aware of which IMP they are receiving). These criteria must be reviewed at all three visits prior to randomisation. Subjects meeting the following criteria will be considered eligible for this study:
    · Willing and able to give written informed consent for participation in the study.
    · Male or female, aged 18 years or above.
    · Subject is able (in the investigator’s opinion) and willing to comply with all study requirements.
    · Diagnosed with any disease sub-type of MS of at least six months duration.
    · Spasticity due to MS of at least three months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
    · The subject has at least moderate spasticity (as defined by a score of ≥4 using a single spasticity severity NRS) at Visit 1.
    · Subject fulfils at least one of the two criteria below. Subject must be either:
    - Currently established on a regular dose of anti-spasticity therapy, or
    - Previously tried and failed, or could not tolerate suitable anti-spasticity therapy.
    · Subject is currently receiving a stable regimen (for at least 30 days prior to study entry) of all medications that may have an effect on spasticity; and willing to maintain this for the duration of the study. If the subject is currently taking disease-modifying medication, this must be at a stable dose for at least three months prior to the screening visit; the dose must also remain stable for the duration of the study.
    · In the investigator’s opinion, the subject is unaware of which IMP s/he will receive in Phase A.
    · Willing for his or her name to be notified to his or her primary care physician, and consultant and the responsible authorities for participation in this study, as applicable.

    At Entry into Phase A – Single blind (i.e. Visit 2)
    In order to remain eligible, the single blind status of Phase A must be maintained (i.e. subject should not be made aware of which IMP they will receive).
    In order to continue in Phase A of the study, ALL subjects must meet the following additional criteria:
    · Subjects have registered spasticity NRS scores via the IVRS over the six days (A2 to A7) from Visit 1. Subjects who are non-compliant will be deemed ineligible to continue.
    · Subject has at least moderate spasticity at Visit 2: NRS spasticity scores, as recorded by the subject on all screening days (A2 to A7), sum to at least 24 (e.g. a score of 4 x 6 days).
    · Subject has had a stable regimen (throughout Phase A) of all medications that may have an effect on spasticity or MS, and remains willing to maintain this for the duration of the study.
    · In the investigator’s opinion, the subject is unaware of which IMP s/he will receive in Phase A.

    At Entry into Phase B/Randomisation (i.e. Visit 3) – Double Blind
    In order to remain eligible, the single blind status of Phase A must be maintained (i.e. subject should not be made aware of which IMP they have received) and subjects must not be informed that they may be changing IMP.
    In order to proceed to randomisation, ALL subjects must meet the following additional criteria:
    · The subject must have had at least a 20% reduction (comparing Weeks 1 and 5) in weekly mean NRS spasticity score, as recorded via IVRS, (i.e. defined as having the capacity to respond to treatment with Sativex).
    · Subject has had a stable regimen (throughout Phase A) of all medications that may have an effect on spasticity or MS, and remains willing to maintain this for the duration of the study.
    · Subject has complied fully with all study procedures including the completion of the spasticity NRS scores during Week 5. Subjects who are non-compliant will be deemed ineligible to continue.
    · In the investigator’s opinion, the subject is unaware of which IMP s/he has received in Phase A.
    E.4Principal exclusion criteria
    Exclusion Criteria:
    The subject may not enter/continue in the study if ANY of the following apply at any study visit prior to randomisation:
    · Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject’s level of spasticity.
    · Subject’s medical history suggests that relapse/remission is likely to occur during the study (over the next 19 weeks) which, in the opinion of the investigator, is expected to influence the subject’s spasticity.
    · Currently receiving a prohibited medication and unwilling to stop for the stated period prior to the screening visit and for the duration of the study.
    · Any known or suspected history of:
    - schizophrenia or other psychotic illness.
    - diagnosed dependence disorder.
    - poorly controlled epilepsy or recurrent seizures.
    - hypersensitivity to cannabinoids.
    · Significant cardiac, renal or hepatic disease.
    · Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.
    · Female subject who is pregnant, lactating or planning pregnancy during the course of the study or for three months thereafter.
    · Subjects who have received an IMP within the 12 weeks before Visit 1.
    · 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, or may influence the result of the study, or the subject’s ability to participate in the study.
    · Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator, would prevent them from safely participating in the study.
    · Unwilling to abstain from donation of blood during the study.
    · Travel outside the country of residence planned during the study.
    · Subjects previously randomised into this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean spasticity NRS score over the last seven days of the evaluable period (end of treatment - usually week 17) in those subjects who demonstrated a response in Phase A.
    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) 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 Yes
    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
    Phase A- single blind, Phase B- double blind, randomised, placebo controlled, parallel group 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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-08. Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 488
    F.4.2.2In the whole clinical trial 488
    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 Decision2008-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-19
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