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    Summary
    EudraCT Number:2005-005265-11
    Sponsor's Protocol Code Number:GWMS0501
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-24
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-005265-11
    A.3Full title of the trial
    A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.

    This will be followed by a 12 week open label treatment phase and then a 4 week randomised withdrawal phase (Part B) for a subset of subjects.
    A.4.1Sponsor's protocol code numberGWMS0501
    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 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 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
    Relief of central neuropathic pain in subjects with 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 Sativex® compared with placebo, when added to existing treatment regimens, in relieving neuropathic pain in subjects with MS.

    Phase B (Open label/Randomised withdrawal phase) -
    To investigate the maintenance of efficacy after long term treatment with Sativex in the indication of central pain in multiple sclerosis. Assesment of the abscence or occurence of withdrawal symptoms.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of Sativex® compared with placebo on:·
    -Secondary measures of pain relief
    -Brief Pain Inventory (BPI)
    -Subject Global Impression of Change·
    -Sleep quality

    To assess the safety and tolerability of Sativex®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting the following criteria will be considered eligible for this study:
    1. Subjects aged 18 years or above.
    2. Diagnosed with any disease sub-type of multiple sclerosis (MS) of at least two years duration.
    3. Central neuropathic pain (CNP) due to MS, of at least three months and which is expected to remain stable for the duration of the study.
    4. Subject has at least moderate CNP, which is defined by: NRS pain scores on all of baseline days B2 to B7 have been recorded, via the IVRS, by the subject and sum to at least 24.
    5. Subject fulfils at least one of the two criteria below. Subject must be either:
    - Currently established on a regular dose of analgesic therapy for their CNP
    - Previously tried and failed or could not tolerate analgesic therapy for their CNP.
    6. Stable medication regimen for at least 2 weeks prior to study entry, for all medications that may have an affect on neuropathic pain, except paracetamol/acetaminophen.
    7. Subject is willing to stop taking their own paracetamol/acetaminophen or paracetamol/acetaminophen containing medications and start using study medication paracetamol/acetaminophen as required (prn) for the duration of the study.
    8. Subject is willing to maintain a stable dose of medications that may have an effect on neuropathic pain, other than study medication and paracetamol/acetaminophen, for the duration of the study.
    9. If the subject is taking disease modifying medication this must be at a stable dose for 3 months prior to the screening visit.

    Part B Visit 6 - Study entry prior to receiving open label study medication.

    For inclusion into Part B of the study, subjects must fulfil ALL of the following criteria:

    1. Subject has participated in GWMS0501, is currently ongoing in the study (i.e., subject is still receiving study treatment) and has completed the study up to Visit 6.
    2. Subject has complied with all of the study requirements to-date.
    3. Subject has at least a 90% compliance rate in the completion of the daily IVRS calls.
    4. Subject has a mean dose of three or more sprays per day over the seven days prior to visit 6.
    5. Subject has shown tolerability to the study medication in this study.
    6. Subject is willing and able (in the investigators opinion) to comply with all study requirements, including the completion of the daily IVRS calls.

    Part B Visit 6c - Following the 12 week open label treatment phase before entry into the double-blind randomised withdrawal phase.

    For inclusion in to the randomised withdrawal phase of the study, subjects must fulfill ALL of the following criteria:
    7. Subject is currently ongoing in Part B of GWMS0501 (i.e., subject is still receiving study treatment) and has completed the study up to visit 6c.
    8. Subject has complied with all of the study requirements to-date.
    9. Subject has at least a 90% compliance rate in the completion of the daily IVRS calls.
    10. Subject has a mean dose of three or more sprays per day over the seven days prior to visit 6c.
    11. Subject is willing to maintain a stable medication regimen for all medications that may have an effect on neuropathic pain.
    12. Subject has shown tolerability to the study medication in this study.
    13. Subject is willing and able (in the investigators opinion) to comply with all study requirements, including the completion of the daily IVRS calls.
    E.4Principal exclusion criteria
    The subject may not enter the study if ANY of the following apply:
    1. Subjects whose identified pain is likely to be of a nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic origin, or is due to trigeminal neuralgia.
    2. Other pain which is not of a central neuropathic origin thought by the investigator to be of a nature or severity to interfere with the subject’s assessment of neuropathic pain due to MS.
    3. Subjects medical history suggests that relapses/remission are likely to occur during the study (the next 15 weeks) which are expected to influence the subjects CNP.
    4. Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study.
    5. Currently using or has used recreational cannabis, medicinal cannabis (including Sativex®), or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration for the study.
    6. Any known or suspected history of:
    - or family history of schizophrenia, other psychotic illness;
    - alcohol or substance abuse
    - epilepsy or recurrent seizures
    - hypersensitivity to cannabinoids
    7. Significant cardiac, renal or hepatic impairment.
    8. If female, is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
    9. Travel outside the country of residence planned during the study.
    10. Subjects who have received an IMP within the 12 weeks before the screening visit.

    Part B Visit 6 and all subsequent Part B visits:

    The subject may not enter Part B of the study if the following applies:

    1. The subject has experienced or is currently experiencing any adverse events or untoward medical occurrences which, in the opinion of the investigator, would prevent them from safely participating in part B of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean pain due to MS NRS score taken from the daily IVRS diaries over the last seven days at the end of treatment during the evaluable period (usually week 14).

    The variable for analysis will be the proportion of subjects showing a response (defined as an improvement of 30% or more in their mean pain NRS score from baseline to the primary endpoint).

    Part B

    The primary endpoint is the time to treatment failure from the randomised phase of Part B of the study.
    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 No
    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
    Part B - 12 week open label and 4 week, double blind, placebo controlled, randomised withdrawal
    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 concerned7
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months6
    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 2006-08-24. 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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 292
    F.4.2.2In the whole clinical trial 312
    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 Decision2006-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-30
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