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    Summary
    EudraCT Number:2011-002258-30
    Sponsor's Protocol Code Number:M/SATIVX/01
    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:2012-04-10
    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 number2011-002258-30
    A.3Full title of the trial
    NEUROPHYSIOLOGIC STUDY AIMED AT EVALUATING ON EFFECT OF SATIVEX® ON SPASTICITY IN PROGRESSIVE MULTIPLE SCLEROSIS
    studio neurofisiologico per valutare l'effetto del sativex sulla spasticita' in sclerosi multipla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF Sativex in relieving pain PEOPLE AFFECTED BY MULTIPLE SCLEROSIS
    STUDIO CLINICO PER VALUTARE L'EFFICACIA DEL SATIVEX NELL'ALLEVIARE IL DOLORE ALLE PERSONE COLPITE DA SCLEROSI MULTIPLA
    A.3.2Name or abbreviated title of the trial where available
    M/SATIVX/01
    M/SATIVX/01
    A.4.1Sponsor's protocol code numberM/SATIVX/01
    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 SponsorALMIRALL PRODESFARMA
    B.1.3.4CountryItaly
    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 supportALMIRALL S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALMIRALL S.A.
    B.5.2Functional name of contact pointGlobal Medical Affairs, GM&MA
    B.5.3 Address:
    B.5.3.1Street AddressRONDA GENERAL MITRE 151
    B.5.3.2Town/ cityBARCELLONA
    B.5.3.3Post code08022
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932913490
    B.5.5Fax number0034932913700
    B.5.6E-mailcarlos.vila@almirall.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 Yes
    D.2.1.1.1Trade name SATIVEX
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Oromucosal spray
    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 INNCANNABIDIOL
    D.3.9.1CAS number 13956-29-1
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDELTA-9-TETRAHYDROCANNABINOL
    D.3.9.4EV Substance CodeSUB27785
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    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 No
    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
    Subject of both male and female gender affected by Secondary-Progressive (SP) or Primary-Progressive (PP) MS
    Soggetti di sesso sia maschile sia femminile affetti da SM secondaria-progressiva (SP) o primaria-progressiva (PP)
    E.1.1.1Medical condition in easily understood language
    Subject of both male and female gender affected by Secondary-Progressive (SP) or Primary-Progressive (PP) MS
    Soggetti di sesso sia maschile sia femminile affetti da SM secondaria-progressiva (SP) o primaria-progressiva (PP)
    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 SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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 effect of Sativex (THC:CBD 1:1 ratio oromucosal spray) compared to placebo in modifying neurophysiological measures of spasticity (H/M ratio scores at baseline and at week 4) in patients affected by lower limbs spasticity in Progressive Multiple Sclerosis
    Valutare l’effetto di Sativex (spray oromucosale di THC:CBD in rapporto 1:1) rispetto al placebo sulla modifica di parametri neurofisologici della spasticità (H/M ratio in visita basale e week 4)nei soggetti affetti da spasticità nei arti inferiori in SM progressiva
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of Sativex compared to placebo on neurophysiological and functional measures, spasticity, pain, sleep and fatigue symptoms • To evaluate safety and tolerability of Sativex
    • Valutare l’efficacia di Sativex rispetto al placebo su misurazioni funzionali secondarie, spasticità, dolore, sonno e sintomi di affaticamento • Valutare la sicurezza e la tollerabilità di Sativex
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged 18 years or above Willing and able to comply with the protocol for the duration of the study Diagnosis of Secondary-Progressive or Primary-Progressive MS from at least12 months Relapse free from at least 3 months before screening visit Lower limb spasticity EDSS from >3.0 and < 6.5 Moderate to severe spasticity due to MS from at least 6 months and with stable drug treatment not able to relieve symptoms as a whole, deserving a specific add-on treatment Immunomodulatory or immunosuppressant therapies not modifed during the study and 6 months before starting the study Stable doses of anti-spasticity agents from at least 2 months prior to screening visit Have given written informed consent
    Di età uguale o superiore a 18 anni Disposti e in grado di rispettare il protocollo per tutta la durata dello studio Diagnosi di SM secondaria-progressiva o primaria-progressiva da almeno 12 mesi Senza recidive da almeno 3 mesi prima della visita di screening Spasticità degli arti inferiori EDSS da &gt;3,0 a &lt; 6,5 Spasticità da moderata a grave dovuta a SM da almeno 6 mesi e con trattamento farmacologico stabile generalmente non in grado di alleviare i sintomi, che necessita di uno specifico trattamento aggiuntivo Terapie immunomodulatorie o immunosoppressive non modificate durante lo studio e per i 6 mesi precedenti l’avvio dello studio Dosi stabili di farmaci antispastici da almeno 2 mesi prima della visita di screening Hanno fornito il proprio consenso informato per iscritto
    E.4Principal exclusion criteria
    Any concomitant disease that may cause spasticity or that could interfere with subject’s spasticity Botulinum Toxin injection for spasticity in the 4 months prior to screening visit Any known or suspected history of psychotic illness, alcohol or substance abuse, epilepsy, hypersensitivity to cannabinoids Significant cardiac, renal or hepatic disease Female subjects of child bearing potentials and male subjects whose partner is child bearing potential, unless willing to ensure that they or their partner use contraception during the study Female subjects who is pregnant lactating or planning pregnancy during the course of the study and for three months thereafter Sativex SmPC contraindications
    Qualsiasi patologia concomitante che potrebbe causare spasticità o che potrebbe interferire con la spasticità del paziente Iniezioni di tossina botulinica per la spasticità nei 4 mesi precedenti la visita di screening Qualsiasi anamnesi nota o sospetta di patologia psicotica, abuso di alcool o droghe, epilessia, ipersensibilità ai cannabinoidi Significativa patologia cardiaca, renale o epatica Soggetti di sesso femminile potenzialmente fertili e soggetti di sesso maschile la cui compagna è potenzialmente fertile, a meno che non siano disposti ad assicurare l’uso di contraccettivi durante lo studio Soggetti di sesso femminile in stato di gravidanza o allattamento, o che stanno pianificando una gravidanza durante il corso dello studio e per i tre mesi seguenti il suo termine Controindicazioni di Sativex SmPC
    E.5 End points
    E.5.1Primary end point(s)
    • To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at baseline and week 4.
    • To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at baseline and week 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    BASELINE VISIT 1 WEEK 4
    VISITA BASALE VISITA 1 SETTIMANA 4
    E.5.2Secondary end point(s)
    Neurophysiology H/M ratio: To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at weeks 6 and 10 Transcranial Magnetic Stimulation Motor threshold to obtain MEPs to the upper limb (time 0-4; 6-10 weeks); MEPs amplitudes at 15% above motor threshold, measured as MEP/M ratio to APB (abductor pollicis brevis) and abductor of hallucis, in which M is the compound muscle potential in response to peripheral stimulation (time 0-4; 6-10 weeks); Intracortical facilitation/inhibition (ICI/ICF) to the upper limb (time 0-4; 6-10 weeks); Spasticity: Mean spasticity score recorded using a 0-10 11-point numerical spasticity rating scale (NRS) at baseline (pre-treatment) and week 4, 6 and 10 Mean modified Ashworth (MAS) score at baseline (pre-treatment), week 4, 6, 10 Function: Mean Timed 25 feet and 10 meters walk recorded at baseline (pre-treatment) and week 4, 6, 10 Mean Hand dexterity measured with 9-HPT recorded at baseline (pre-treatment) and week 4, 6, 10 Other MS Symptoms: Mean Sleep Quality NRS recorded at baseline (pre-treatment) and week 4, 6, 10 Pain NRS and Spasm frequency recorded at baseline (pre-treatment) and week 4, 6, 10 Fatigue measured with the Fatigue Severity Scale (FSS) recorded at baseline (pre-treatment) and week 4, 6, 10
    Neurofisiologia • Valutare le differenze nei punteggi dell’H/M ratio nei soggetti affetti da SM progressiva alle settimane 6 e 10 Stimolazione Magnetica Transcranica • Motore, soglia di ottenere deputati per l'arto superiore (tempo 0-4, 6-10 settimane); • Ampiezze deputati del 15% al di sopra della soglia del motore, misurata come europarlamentare / M rapporto di APB (abduttore breve del pollice) e rapitore di dell'alluce, in cui M è il potenziale muscolare composto in risposta alla stimolazione periferica (tempo 0-4; 6-10 settimane ); • Intracorticale facilitazione / inibizione (ICI / ICF) per l'arto superiore (tempo 0-4, 6-10 settimane); Spasticità: • Punteggio medio spasticità registrati con un 00-10 a 11 punti numerica scala di valutazione della spasticità (NRS) al basale (pre-trattamento) e la settimana 4, 6 e 1 Significa Ashworth modificata (MAS) punteggio al basale (pre-trattamento), settimana 4, 6, 10 Funzionalità: • Tempo medio di cammino per 25 piedi e 10 metri registrato al basale (pre-trattamento) e alle settimane 4, 6, 10 • Destrezza manuale media misurata con 9-HPT (9–Hole Peg Test) registrato al basale (pre-trattamento) e alle settimane 4, 6, 10 Altri sintomi di SM: • Qualità media del sonno sulla scala NRS registrata al basale (pre-trattamento) e alle settimane 4, 6, 10 • Frequenza di dolore e spasmi sulla scala NRS registrata al basale (pre-trattamento) e alle settimane 4, 6, 10 • Spossatezza misurata per mezzo della scala FSS (Fatigue Severity Scale) registrata al basale (pre-trattamento) e alle settimane 4, 6, 10
    E.5.2.1Timepoint(s) of evaluation of this end point
    BASELINE VISIT VISIT 1 WEEK 4 VISIT 2 WEEK 6 VISIT 3 WEEK 10
    VISITA BASELINE VISITA 1, SETTIMANA 4 VISITA 2, SETTIMANA 6 VISITA 3, SETTIMANA 10
    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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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 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
    Last patient out: August 2012
    LVLS: Agosto 2012
    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 months9
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 36
    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 state40
    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)
    The patients will we treated as the standard clinical practice
    i paziente saranno trattati come de accordo alla pratica clinica abituale.
    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 Decision2011-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
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