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    Summary
    EudraCT Number:2020-004306-58
    Sponsor's Protocol Code Number:GWSP20104
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-25
    Trial 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 ConcernedLithuania - SMCA
    A.2EudraCT number2020-004306-58
    A.3Full title of the trial
    A randomized double-blind placebo-controlled study of nabiximols in patients with spasticity in multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to asses the effects of Nabiximols on spasticity associated with multiple sclerosis.
    A.3.2Name or abbreviated title of the trial where available
    RELEASE MSS4
    A.4.1Sponsor's protocol code numberGWSP20104
    A.5.4Other Identifiers
    Name:IND NUMBERNumber:140706
    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 Limited
    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 Pharma Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Pharma Ltd
    B.5.2Functional name of contact pointRegulatory Affairs Manager
    B.5.3 Address:
    B.5.3.1Street AddressSovereign House, Vision Park, Chivers Way, Histon
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB24 9BZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441223266800
    B.5.5Fax number441223235667
    B.5.6E-mailgwreg@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 nameNabiximols - Sativex
    D.3.4Pharmaceutical form Oromucosal spray, 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 INNTetrahydrocannabinol Botanical Drug Substance (THC BDS)
    D.3.9.1CAS number 1972-08-3
    D.3.9.3Other descriptive nameDELTA-9-TETRAHYDROCANNABINOL
    D.3.9.4EV Substance CodeSUB27785
    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.3.8INN - Proposed INNCannabidiol Botanical Drug Substance (CBD BDS)
    D.3.9.1CAS number 13956-29-1
    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 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) 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 placeboOromucosal spray, 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
    Symptomatic treatment of spasticity in patients with MS
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis (MS)
    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 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 establish the efficacy of nabiximols relative to placebo on spasm frequency in MS patients with spasticity.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    1. To evaluate the effect of nabiximols on spasticity using the 11-point NRS for spasticity.
    2. To evaluate the safety and tolerability of nabiximols after administration of multiple doses.

    Exploratory Objectives:
    1. To evaluate the effect of nabiximols on spasm severity using the 11-point NRS spasm severity scale
    2. To evaluate the effect of nabiximols relative to placebo on other symptoms associated with MS, using the following patient-reported outcomes:
    − PSQI
    − OAB-q-SF
    − MSISQ19
    − To evaluate the effect of nabiximols on the impact of spasticity in MS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is male or female, aged 18 years or above.
    2. Patient is willing and able to give informed consent for participation in the trial.
    3. Patient is willing and able (in the investigator’s opinion) to comply with all trial requirements.
    4. Willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
    5. Patient is willing to allow his or her primary care practitioner (if they have one) or consulting neurologist (if they have one) to be notified of participation in the trial, if the primary care practitioner/consultant is different to the investigator.
    6. Patient has a diagnosis with any disease subtype of MS, by revised 2017 McDonald criteria, for at least 12 months before Visit 1 (screening) and is expected to remain stable for the duration of the trial.
    7. For patients not receiving any current antispasticity medications they must have been off of any antispasticity medication (e.g., oral or intrathecal baclofen, tizanidine, and/or oral dantrolene) for 30 days prior to Visit 1 (screening) and is not planning to start any antispasticity medication during the trial; and must not plan to initiate a new course of physiotherapy for the duration of the trial.
    8. For those on antispasticity medication (oral or intrathecal baclofen, oral tizanidine, and/or oral dantrolene) these medications must be optimized and stable for at least 30 days prior to Visit 1. Despite optimization, the patient does not have adequate relief of spasticity signs and symptoms, including muscle spasms. Optimization of antispasticity medications is defined as having reached the most efficacious and best tolerated dose according to the relevant local prescribing information. The patient must be willing to maintain the same antispasticity medication and not plan to initiate a new course of physiotherapy for the duration of the trial.
    9. If currently receiving an approved MS disease-modifying therapy, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
    10. If currently receiving dalfampridine or fampridine, it must be at a stable dose for at least 3 months prior to Visit 1 and is expected to remain stable for the duration of the trial.
    Patients are eligible for the treatment period if, in addition to continuing to meet the screening (Visit 1) inclusion criteria, they also meet ALL of the following criteria immediately prior to Visit 2:
    11. Patient has completed at least 12 of the last 14 days of their eDiary reporting immediately prior to Visit 2.
    12. Patient has an average daily spasm count of ≥ 4 during the screening period, as recorded in the eDiary.
    13. Patient has no more than 35 spasms on a single day of the screening period, as recorded in the eDiary.
    14. Patient does not have > 7 consecutive days without experiencing any spasm during screening.
    15. Patient completed at least 12 of the last 14 days of their eDiary reporting immediately prior to Visit 4.
    E.4Principal exclusion criteria
    The patient may not enter the trial if ANY of the following apply:
    1. History of severe psychiatric disorder that may be exacerbated by the use of a cannabinoid-containing product.
    2. Relapse of MS within the 60 days prior to Visit 1.
    3. Patient’s medical history suggests that relapse/remission is likely to occur during the trial, which, in the opinion of the investigator, is expected to influence the patient’s spasticity.
    4. Any concomitant disease or disorder that has spasticity-like symptoms that may influence the patient’s level of spasticity.
    5. Planned clinical interventions or intention to change any medications that may have an effect on spasticity or MS during the trial.
    6. Plans to initiate a new course of physiotherapy during the course of the trial.
    7. Patient has any known or suspected hypersensitivity to cannabinoids or any of the excipients of nabiximols, or any other cannabinoid-containing products used for therapeutic purposes.
    8. Currently taking antipsychotic medications.
    9. Botulinum toxin injection for the relief of spasticity (within 6 months of Visit 1) or is unwilling to abstain for the duration of the trial.
    10. Received an IMP within the 30 days prior to Visit 1.
    11. Patient has travel outside the country and/or US state of residence planned during the trial, unless the patient has confirmation that the IMP is permitted in the destination country/state.
    12. Current use or use of cannabis or a cannabinoid-derived product for medicinal or recreational use within 30 days of Visit 1, or is unwilling to abstain for the duration of the trial.
    13. Currently taking benzodiazepines, unless doses and dosing regimen have been stable for at least 30 days prior to Visit 1.
    14. Previous participation in a clinical trial of nabiximols.
    15. Have been in close contact with persons with diagnosed or suspected COVID-19 in the last 2 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints:
    - Change in the average daily spasm count (the last 14 days prior to Visit 7) compared to the average daily spasm count at baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Spasm count recorded in ediary from visit 1 to 7.
    - Change in the average daily spasm count (the last 14 days prior to Visit
    7) compared to the average daily spasm count at baseline (the last 14 days prior to the date of randomization
    E.5.2Secondary end point(s)
    Secondary endpoint:
    - Change from baseline in average daily 11-point NRS spasticity to the last 14 days prior to Visit 7.

    - To evaluate the safety and tolerability of multiple dose administrations of nabiximols

    Change from baseline to each assessment timepoint by treatment period for the following:
    − Adverse Events (AE's) − Clinical laboratory parameters (hematology, coagulation, biochemistry, and urinalysis)
    − Vital signs (systolic/diastolic blood pressure, heart rate, respiratory rate, and body temperature)
    − Physical examination − 12-lead ECGs
    - C-SSRS at screening (Visit 1), and at each subsequent timepoint with reference to the last assessment (since last visit)

    The exploratory endpoints are as follows:
    • Change from baseline in the PSQI at 14 days prior to Visit 7
    • Change from baseline in OAB-q-SF at 14 days prior to Visit 7
    • Change from baseline in MSISQ19 at 14 days prior to Visit 7
    • Change from baseline in the MSSS-88 at 14 days prior to Visit 7
    • Change from baseline in average daily 11-point NRS spasm severity score to the last 14 days prior to Visit 7
    E.5.2.1Timepoint(s) of evaluation of this end point
    - AE's - visit 1-8, Clinical lab tests visit 1,2,4,5 and 7.
    - Vital signs and ECG visit 1 and 2 and visits 4-7.
    - Physical examination visit 1 and 7.
    - CSSR and NRS (ediary) visit 1-7.
    - PSQI, OAB-q-SF, MSISQ19, MSSS-88 visits 2,4,5 and 7
    - For eDiary endpoints, baseline is defined as the last 14 days prior to the date of randomization.
    - For visit-based endpoints, baseline is defined as the last measurement collected prior to the first dose of randomized IMP.
    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
    Enriched
    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 EEA43
    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
    Bulgaria
    Canada
    Hungary
    Italy
    Lithuania
    Spain
    United Kingdom
    United States
    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 last visit or last contact, whichever occurs last.
    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 months
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 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: 483
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 92
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 317
    F.4.2.2In the whole clinical trial 575
    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)
    There will be no post-trial provision of nabiximols.
    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 Decision2022-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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