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    Summary
    EudraCT Number:2012-005328-14
    Sponsor's Protocol Code Number:SATIVEX-2013
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-04-16
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-005328-14
    A.3Full title of the trial
    Effect of Sativex on neuropathic pain and spasticity following spinal cord injury
    Effekten af Sativex på neuropatiske smerter og spasticitet hos rygmarvsskadede
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Sativex on pain and spasticity following spinal cord injury
    Effekten af Sativex på nervesmerter og spasticitet hos rygmarvsskadede
    A.4.1Sponsor's protocol code numberSATIVEX-2013
    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 SponsorSpinal Cord Injury Centre of Western Denmark
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGW Pharmaceuticals plc
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportRegionshospitalet Viborg
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpinal Cord Injury Centre of Western Denmark
    B.5.2Functional name of contact pointForskningsenheden
    B.5.3 Address:
    B.5.3.1Street AddressSoendersoeparken 21
    B.5.3.2Town/ cityViborg
    B.5.3.3Post code8800
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4578446150
    B.5.5Fax number+4578446159
    B.5.6E-mailsven.robert.andresen@midt.rm.dk
    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, Oromucosal Spray
    D.2.1.1.2Name of the Marketing Authorisation holderGW Pharma Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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, Oromucosal Spray
    D.3.2Product code 47794
    D.3.4Pharmaceutical form Oromucosal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.11 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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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, 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
    Neuropathic pain and spasticity following spinal cord injury
    Neuropatisk smerte og spasticitet hos rygmarvsskadede
    E.1.1.1Medical condition in easily understood language
    Pain and spasticity following spinal cord injury
    Nervesmerte og spasticitet hos rygmarvsskadede
    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 LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10041416
    E.1.2Term Spasticity
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10041552
    E.1.2Term Spinal cord injury
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary purpose is to study the effect of Sativex on neuropathic pain and spasticity following spinal cord injury.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate different pain and spasticity measures the effect on allodynia and hyperalgesia and impact on activities, mood, sleep and escape medication, after the use of Sativex.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Neuropathic pain and / or spasticity after spinal cord injury / disease duration of at least 3 months, spinal cord injury must be at least 6 months prior to enrollment. The average intensity of the pain, respectively. spasticity measured on a numerical rating scale (NRS) (0-10) must be at least 4 in the baseline period (1 week). Age 18 years. Given informed consent.
    E.4Principal exclusion criteria
    History of stroke or cerebral contusion or other cerebral injury with significant sequelae.
    Patients who can’t cooperate or unable to complete the project due to lack of understanding of Danish
    Pregnant or lactating women. Woman and men (or their partners) must use contraceptives during and three months after the trial has ended.
    Known allergy to cannabinoids (THC / CBD) or excipients.
    Previous or current schizophrenia, psychosis or other serious psychiatric disorder other than depression in the patient or immediate family.
    Concomitant severe pain that can’t be distinguished from the neuropathic pain associated with spinal cord injury
    Terminal illness or patients inappropriate for placebo.
    Planned surgery, anesthesia or travel abroad during the trial.
    History of severe cardiovascular disease, treatment with digoxin, poorly controlled hypertension, epilepsy or history of seizures
    Significant impairment of liver or kidney.
    There should not be use of cannabinoids 3 months before the study or during the study.
    Abuse of cannabinoids, alcohol or medication. Patients who are in Antabus treatment should be excluded from the study due to interaction risk because Sativex contains alcohol.
    E.5 End points
    E.5.1Primary end point(s)
    The difference in mean value of patients daily rating of average pain intensity on NRS (0-10) in the last 7 days of each treatment period. Change from baseline to the last week of each treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and 6 weeks treament
    E.5.2Secondary end point(s)
    - Combined pain and spasticity score
    - Pain relief (overall, at-level and below-level) and reduction of spasticity after each treatment period. For spasticity noted the overall and separately for spasms and stiffness
    -Number of patients with 33% and 50% reduction of pain and/or spasticity.
    - The effect on various pain symptoms assessed by a questionnaire on neuropathic pain (NPSI)
    - Allodynia and hyperalgesia (mechanical, cold and warm)
    - Sleep disturbance
    - Use of escape medication
    - Spasticity with use of Tardieu Scale, Clonus assessment, Spasms rated on NRS and the Penn Spasm Frequency Scale
    - "Global impression of change" and preference period
    - Number of "responders", patients with 33% pain relief, in the group of patients with allodynia compared with the group without allodynia
    - Pain and spasticity impact on activities, mood and sleep
    - Adverse effects
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline and 6 weeks treament
    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 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 concerned2
    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
    LVLS
    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 months0
    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.1.1.1In 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    At the end of the patients participation in the trial, the doctor will discuss furture treatment of pain and spasticity with the patient. It is expected to be the normal treatment used for patients with spinal cord injury.
    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 Decision2013-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-07-02
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