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    Summary
    EudraCT Number:2004-002531-32
    Sponsor's Protocol Code Number:GWCL0405
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-002531-32
    A.3Full title of the trial
    A double blind, randomised, placebo controlled, parallel group study of Sativex, in the treatment of subjects with peripheral neuropathic pain associated with allodynia
    A.3.2Name or abbreviated title of the trial where available
    N/a
    A.4.1Sponsor's protocol code numberGWCL0405
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Peripheral neuropathic pain associated with allodynia
    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 in relieving peripheral neuropathic pain associated with allodynia.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of Sativex compared with placebo on:
    - proportion of subjects showing an improvement of 30% or more and 50% or more in their primary endpoint from baseline to end of study
    - secondary measures of pain relief
    - sleep quality
    - quality of life
    To assess the safety and tolerability of Sativex
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Subject is willing and able to give informed consent for participation in the study
    2. Male or female, aged 18 years or above
    3. Subject is able (in the investigators opinion) and willing to comply with all study requirements
    4. Diagnosed with peripheral neuropathic pain of at least 6 months duration and in who pain is not wholly relieved with their current therapy
    5. Subject must have presence of mechanical allodynia within the territory of the affected nerve(s). This should be confirmed by a positive pain response to either stroking the allodynic area with a SENSELAB brush 05 or to force applied by a 5.07 gram Semmes-Weinstein monofilament.
    6. Subject must have at least one of the following underlying conditions, which causes their peripheral neuropathic pain;
    - postherpetic neuralgia, peripheral neuropathy, focal nerve lesion, or complex regional pain syndrome (CRPS) type 2. Note: CRPS type 1 is excluded
    7. Stable dose of regular pain medication and non-pharmacological therapies (including TENS) for at least 14 days prior to the screening visit and willing for these to be maintained throughout the study. Where patients are taking a medication containing paracetamol please refer to section 8.3
    8. Has the subject, in the opinion of the investigator, received or is currently receiving the appropriate peripheral neuropathic pain treatments for their condition
    9. Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries
    10. Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study
    E.4Principal exclusion criteria
    1. Concomitant pain thought by the investigator to be of a nature or severity to interfere with the subject's assessment of their peripheral neuropathic pain
    2. Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study
    3. CRPS type 1, cancer related neuropathic pain or neuropathic pain resulting from diabetes mellitus
    4. Subjects who haveused within the last year, or who are currently using, either cannabis (either for recreational or medical purposes) or cannabis based medicines and who are unwilling to abstain for the duration of the study
    5. Any history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
    6. Any Known or suspected history of alcohol or substance abuse
    7. Any history of epilepsy or recurrent seizures
    8. Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication
    9. Subject has evidence of cardiomyopathy
    10. Subject has experienced myocardial infarction or clinically relevant cardiac dysfunction withinthe last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction
    11. Subject has a QT interval of > 450 ms (males) or > 470 ms (females) at visit 1
    12. Subject has a secondary or tertiary AV block or sinus bradycardia (HR < 50 bpm) or sinus tachycardia (HR > 110 bpm) at visit 1
    13. Subject has a diastolic blood pressure of < 50 mmHg or >105 mmHg in a sitting position at rest for 5 minutes prior to randomisation
    14. Subject has impaired renal function i.e. creatinine clearance is lower than 50 ml/min at visit 1
    15. Subject has significantly impaired hepatic function, at visit 1, in the investigators opinion
    16. 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
    17. Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
    18. Subjects who have received an IMP within the 12 weeks before visit 1
    19. 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, may influence the result of the study, or the subject's ability to participate in the study
    20. Following a medical exam, the subject has any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study
    21. Unwilling to abstain from donation of blood during the study
    22. Travel outside the country of residence planned during the study
    23. Subjects previously randomised into this study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean 11-point numeric rating scale (NRS) peripheral neuropathic pain score during weeks 13 and 14 of treatment (end of treatment) taken from the daily diaries.
    The variable for analysis will be the change in mean NRS, from baseline to the end of the treatment.
    See section 12.6.1 for full detailsof the analysis
    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 Information not present in EudraCT
    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.8.3 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.8.5The 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 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 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    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 2006-08-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 218
    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)
    Subjects will be offered the opportunity to participate in a 9 month open label study with the same product. If they do not wish to take part then their medical care will continue as before the clinical trial.
    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 Decision2006-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-10-18
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