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    Summary
    EudraCT Number:2006-005910-11
    Sponsor's Protocol Code Number:GWSP0604
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-23
    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 ConcernedItaly - Italian Medicines Agency
    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.
    Studio clinico di Fase 3 condotto in due fasi atto a determinare la sicurezza ed efficacia di Sativex, farmaco destinato ad alleviare i sintomi della spasticita` nei soggetti affetti da sclerosi multipla: Fase A: valutazione della risposta in singolo cieco; Fase B: studio a gruppi paralleli in doppio cieco, randomizzato, controllato con placebo.
    A.3.2Name or abbreviated title of the trial where available
    Study of Sativex in subjects with spasticity due to MS
    A.4.1Sponsor's protocol code numberGWSP0604
    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 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.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOther analgesics and antipyretics
    D.3.9.1CAS number 1972-08-3
    D.3.9.2Current sponsor codeGW-1000-02
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    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 No
    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 placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Sclerosis
    Sclerosi Multipla
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system 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 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.
    Valutazione dell'efficacia del farmaco GW-1000-02 (commercializzato in Canada con il nome Sativex e noto anche con il nome spray orale Sativex) rispetto a un placebo nel sollievo dei sintomi della spasticita' provocata dalla sclerosi multipla (MS), nei soggetti in cui e' stata individuata la capacita' di rispondere a 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.
    Valutazione dell'effetto di Sativex rispetto a un placebo sulle: • Misurazioni secondarie della spasticita'.• Misurazioni funzionali della spasticita'.Valutazione della sicurezza e della tollerabilita' di Sativex.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening (Visit 1) 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 and willing to comply with all study requirements. •Diagnosed with any disease sub-type of MS of at least 6 months duration. •Spasticity due to MS of at least 3 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 &#8805;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. •Stable regimen of spasticity and disease modifying medications and 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. •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 (Visit 2) •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). •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 (Visit 3) - Double Blind 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 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.
    Screening (V1)• in grado di rendere il proprio consenso informato scritto alla partecipazione allo studio.
    • Ambosessi, &#8805; 18 anni
    • Soggetto che (secondo lo sperimentatore) accetta ed e' in grado di rispettare tutti i requisiti dello studio.
    • Diagnosi di patologia sotto-tipo di MS della durata di almeno sei mesi.
    • spasticita' da MS da almeno tre mesi, non completamente alleviata dalla terapia antispastica attualmente in corso, di cui e che si prevede rimanga stabile per la durata dello studio.
    • spasticita' perlomeno moderata (come definita da un dal punteggio di &#8805;4 della scala NRS) alla Visita 1.
    • Il soggetto soddisfa almeno uno dei due criteri indicati qui di seguito. Il soggetto deve essere:
    - Attualmente trattato con una dose regolare stabile di antispastici oppure
    - E' gia' stato sottoposto ad idonea terapia antispastica non tollerata o con esito negativo.
    • Al soggetto vengono attualmente somministrati regolarmente e ad un dosaggio stabile (da almeno 30 giorni prima della partecipazione allo studio clinico) tutti i farmaci che possono avere un effetto sulla spasticita'; e il soggetto e' disposto a continuare a sottoporsi a questa terapia per l'intera durata dello studio. Se il soggetto sta attualmente assumendo un farmaco in grado di modificare l'andamento della malattia, la dose di questo farmaco deve essere una dose stabile per da almeno tre mesi prima della visita di screening e deve rimanere tale per la durata dello studio.
    • Secondo lo sperimentatore, non e' a conoscenza di quale IMP gli/le verra' somministrato nella Fase A.
    Fase A
    • Devono avere comunicato i punteggi NRS della spasticita' attraverso l'IVRS negli ultimi sei giorni (da A2 a A7) dalla Visita 1. I soggetti che non avranno soddisfatto questo requisito non potranno piu' continuare a partecipare allo studio.
    • A Visita 2 devono avere una spasticita' almeno moderata: la somma dei punteggi di spasticita' NRS, comunicati dai soggetti tutti i giorni di screening (da A2 a A7), e' almeno 24 (ad es. un punteggio di 4 x 6 giorni).
    • Hanno assunto regolarmente e ad un dosaggio stabile (durante la Fase A) tutti i farmaci che possono avere effetto sulla spasticita' o sulla MS, e sono disposti a continuarne l'assunzione stabilmente per l'intera durata dello studio.
    • Secondo lo sperimentatore il soggetto non e' a conoscenza di quale IMP gli/le verra' somministrato nella Fase A.
    Fase B
    • Il soggetto deve avere mostrato una riduzione di almeno il del 20% (confrontando le settimane 1 e 5) del punteggio di spasticita' NRS medio, comunicato attraverso l'IVRS, (ovvero ne e' stata determinata la capacita' di rispondere al trattamento con Sativex).
    • Il soggetto ha assunto regolarmente e ad un dosaggio stabile (durante la Fase A) tutti i farmaci che possono avere effetto sulla spasticita' o sulla MS, ed e' disposto a continuarne stabilmente l'assunzione per l'intera durata dello studio.
    • Il soggetto ha rispettato tutte le procedure dello studio clinico, compresa la comunicazione dei punteggi di spasticita' NRS durante la Settimana 5. I soggetti che non rispettano queste procedure non saranno piu' considerati idonei per continuare a partecipare allo studio.
    • Secondo lo sperimentatore, il soggetto non e' a conoscenza di quale IMP gli/le e' stato somministrato nella Fase A.
    E.4Principal 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 subjects 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 (see Section 8.3). •Any known or suspected history of (see Section 6.2): -schizophrenia or other psychotic illness. -diagnosed dependence disorder. -poorly controlled epilepsy or recurrent seizures. -hypersensitivity to cannabinoids. •Significant cardiac, renal or hepatic disease (see Section 6.2). •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.
    Il soggetto non puo' essere ammesso/continuare a partecipare allo studio clinico se, durante una delle visite dello studio prima della randomizzazione, viene riscontrata UNA delle seguenti condizioni: •Il soggetto ha contratto una patologia o un disturbo i cui sintomi sono simili a quelli della spasticita' o che possono influire sul grado di spasticita' del soggetto stesso. •L'anamnesi del soggetto rivela la probabilita' di ricaduta/remissione della patologia durante lo studio clinico (nel corso delle 19 settimane successive) che, secondo l'investigatore, influira' sulla spasticita' del soggetto stesso. •Il soggetto sta assumendo un farmaco proibito e non e' disposto ad interromperne l'assunzione per il periodo previsto prima della visita di screening e durante lo studio (vedi la sezione 8.3). •L'anamnesi del soggetto rivela o induce a sospettare che il soggetto sia stato affetto da (vedi la Sezione 6.2): -schizofrenia o altra patologia psicotica. -disturbo da assuefazione diagnosticato. -epilessia mal controllata o attacchi epilettici frequenti. -ipersensibilita' ai cannabinoidi. •Il soggetto e' affetto da grave patologia cardiaca, renale o epatica (vedi la Sezione 6.2). •Il soggetto femmina e' in eta' feconda o il soggetto maschio ha una compagna in eta' feconda, a meno che non sia disposta/o a confermare che lei/lui o la sua compagna faranno uso di contraccettivi sicuri durante lo studio e per i tre mesi successivi allo studio. •Il soggetto femmina e' incinta, allatta o ha pianificato una gravidanza durante lo studio o per i tre mesi successivi. •E' stato somministrato al soggetto un IMP durante le 12 settimane antecedenti la Visita 1. •Il soggetto e' affetto da una grave patologia o disturbo che, secondo l'investigatore, puo' essere aggravata/o dalla partecipazione del soggetto allo studio, oppure puo' pregiudicare l'esito dello studio, o la capacita' del soggetto di partecipare allo studio. •Dopo un esame medico, il soggetto ha rivelato delle anomalie che, secondo l'investigatore, gli/le impedirebbero di partecipare allo studio in sicurezza. •Il soggetto non e' disposto ad astenersi dal donare sangue durante lo studio. •Il soggetto intende fare viaggi all'estero durante lo studio. •Il soggetto era gia' stato selezionato su base randomizzata per partecipare a questo studio.
    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.
    Il risultato primario e' il punteggio medio di spasticita' della NRS comunicato negli ultimi sette giorni del periodo valutabile (fine del trattamento - in genere la settimana 17) nei soggetti che hanno dimostrato di rispondere al farmaco nella Fase 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 Yes
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=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 Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    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 Decision2008-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-30
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