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    Summary
    EudraCT Number:2019-002394-59
    Sponsor's Protocol Code Number:P142
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-002394-59
    A.3Full title of the trial
    Medical Cannabis for fibromyalgia - The CANNFIB trial
    Protocol for a randomized, double-blind, placebo-controlled, parallelgroup,
    single-center trial
    Medicinsk Cannbis for fibromyalgi - CANNFIB studiet
    Et randomiseret, dobbelblindet, placebokontrolleret, parallel gruppe,
    single-center studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Medical Cannabis for Fibromyalgia
    Medicinsk Cannabis for Fibromyalgi
    A.4.1Sponsor's protocol code numberP142
    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 SponsorThe Parker Institute, Bispebjerg and Frederiksberg Hospital
    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 supportThe Oak Fondation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Danish Rheumatism Association
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportBispebjerg and Frederiksberg Internal research Grant
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportErna Hamilton Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAase and Ejnar Danielsens foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportNordic Cannabis Research
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportLinnea Switzerland
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Parker Institute
    B.5.2Functional name of contact pointMarianne Uggen Rasmussen
    B.5.3 Address:
    B.5.3.1Street AddressNordre Fasanvej 57
    B.5.3.2Town/ cityFrederiksberg
    B.5.3.3Post code2000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538164197
    B.5.5Fax number+4538164159
    B.5.6E-mailmarianne.uggen.rasmussen@regionh.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 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 nameCannabidiol tablet 10 mg
    D.3.2Product code None
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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) 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 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibromyalgia
    Fibromyalgi
    E.1.1.1Medical condition in easily understood language
    Chronic Widespread Pain
    Kroniske generaliserede muskelsmerter
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016631
    E.1.2Term Fibromyalgia syndrome
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of cannabidiol 50 mg compared to
    cannabidiolplacebo,
    on change in pain intensity from baseline to week 24.
    At undersøge effekten af cannabidiol 50 mg sammenlignet med
    cannbidiol-placebo på ændring i smerte intensitet fra baseline til uge 24.
    E.2.2Secondary objectives of the trial
    To assess the effect of cannabidiol 50 mg, compared to
    cannabidiolplacebo,
    on changes in the following secondary key endpoints: Sleep
    quality and duration, activities of daily living, quality of life from baseline
    to week 24.
    At undersøge effekten af cannabidiol 50 mg sammenlignet med
    cannbidiol-placebo på ændring i søvnkvalitet og varighed, dagligdags
    aktivitet og livskvalitet fra baseline til uge 24.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed consent obtained
    Clinical diagnosis of fibromyalgia according to the American College of
    Rheumatology (ACR) 1990 criteria
    Adult individuals (Age ≥18 years and <75 years)
    Average pain intensity ≥ 4 on a Numeric Rating Scale (NRS)
    No use of medical cannabis (THC/CBD) within the last six months
    Proficiency in spoken Danish language and able to read and write in
    Danish
    Underskrevet informeret samtykke
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    Klinisk diagnosticeret med fibomyalgi i henhold til the American College
    of Rheumatology (ACR) 1990 kriterierne
    Voksne i alderen ≥18 til 75 år
    Gennemsnitlig smerteintensitet ≥ 4 på en numerisk smerteskala
    Ingen brug af medicinsk cannabis (THC/CBD) indenfor de sidste seks
    måneder
    I stand til at tale flydende dansk og til at læse og skrive på dansk
    E.4Principal exclusion criteria
    On-going participation in other medical trials for pain management of
    fibromyalgia
    Diagnosis of Rheumatoid Arthritis or other inflammatory diseases
    Diagnosis of other serious chronic diseases
    Impaired liver and kidney function
    Pregnancy or insufficient anti-conception therapy for female fertile
    participants
    Planning pregnancy or insufficient anti-conception use in female fertile
    partners of male participants
    Breast feeding
    Surgery scheduled for the trial period or within 3 months prior to
    enrollment
    History of or current diagnosis of cancer
    History of or current epilepsy and seizures
    History of or major depressive disorder
    History of a suicide attempt or any suicidal behavior
    A mental state impeding compliance with the program
    History of severe psychiatric disorders
    History of or current abusive behavior of cannabis
    History of or current abusive behavior of other drugs
    History of or current abusive behavior of alcohol
    Severe personality disorder
    Current use of opioids, opioid antagonists (LDN) or similar strong
    analgesics
    Allergic reactions to the active ingredients in cannabidiol
    Deltagelse i andre medicinske forsøg med smertehåndtering af
    fibromyalgi
    Diagnoseret med leddegigt eller andre inflammatoriske sygdomme
    Diagnoseret med andre alvorlige kroniske sygdomme
    Nedsat lever- og nyrefunktion
    Graviditet eller utilstrækkelig antikonception terapi for kvindelige
    deltagere i fødedygtig alder
    Planlægning af graviditet eller utilstrækkelig brug af antikonception hos
    kvindelige partnere i fødedygtig alder av mandlige deltagere
    Amning
    Kirurgi planlagt i forsøgsperioden eller inden for 3 måneder før
    tilmelding
    Historisk eller aktuel kræft diagnose
    Historisk eller aktuel epilepsi og anfald
    Historisk eller aktuel alvorlig depressiv lidelse
    Historisk selvmordsforsøg eller selvmordsadfærd
    Mental tilstand, der hindrer overholdelse af programmet
    Historisk eller aktuelle alvorlige psykiatriske lidelser
    Historisk eller aktuelt misbrug af cannabis
    Historisk eller aktuelt misbrug af andre narkotiske stoffer
    Historisk eller aktuelt misbrug af alkohol
    Alvorlig personlighedsforstyrrelse
    Nuværende brug af opioider, opioidantagonister (LDN) eller lignende
    stærke analgetika
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in pain intensity, measured on a 0-10
    Pain Numeric Rating scale (NRS) included in the revised Fibromyalgia
    Impact Questionnaire (FIQ-R). To facilitate interpretation of the pain
    intensity measure, the findings will also be communicated as the
    proportion of patients achieving more than 30% and 50% pain reduction
    on the FIQ-R Pain Numeric Rating scale.
    Det primære endepunkt er ændring i smerteintensitet, målt på en 0-10
    numerisk smerteskala (NRS) som er inkluderet i det reviderede
    Fibromyalgia Impact Questionnaire. Resultaterne af
    smerteintensitetsmålingen, vil også blive kommunikeret som andelen af
    patienter, der opnår mere end 30% og 50% smertereduktion i FIQ-R
    Pain, på den numeriske smerteskala.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 24
    Fra baseline til uge 24
    E.5.2Secondary end point(s)
    Key secondary endpoints are changes in:
    Sleep quality and duration: The Pittsburg Sleep Quality Index, subjective
    sleep quality and duration domains Objectively measured sleep
    duration and patterns: Accelerometer data
    Activities of daily living: The Assessment of Motor and Process Skills and
    Activities of Daily living-Questionnaire Quality of life: The EuroQol Group
    self-rated health questionnaire 5D
    Exploratory secondary endpoints are changes in:
    Sleep latency: The Pittsburg Sleep Quality Index, subjective sleep
    latency domains Pain self-efficacy: The
    Pain Self-Efficacy questionnaire
    Stiffness: Fibromyalgia Impact Questionnaire- revised, stiffness subscale
    Energy level: Fibromyalgia Impact Questionnaire- revised, energy
    subscale Objectively measured
    physical activity: Accelerometer data
    Feeling rested: Fibromyalgia Impact Questionnaire- revised, rested
    subscale Depression: Fibromyalgia
    Impact Questionnaire- revised, depression subscale
    Depression, anxiety and stress: The Depression, Anxiety, Stress Scale
    depression anxiety and stress scale Anxiety level:
    Fibromyalgia Impact Questionnaire- revised, anxiety subscale
    Perceived stress: The Perceived Stress Scale
    Cortisol concentration in hair: Hair clipping analysis
    Memory problems: Fibromyalgia Impact Questionnaire- revised, memory
    subscale Tenderness level (tenderness to
    touch): Fibromyalgia Impact Questionnaire- revised, tenderness
    subscale Balance problems: Fibromyalgia Impact Questionnaire- revised,
    balance subscale Environmental sensitivity:
    Fibromyalgia Impact Questionnaire- revised, environmental sensitivity
    subscale Pressure pain threshold and tolerance: Cuff algometry
    Appetite: The simplified nutritional appetite questionnaire
    Body weight
    Body composition: Bioimpedance
    Body fat distribution: Waist and hip circumferences
    Prioriterede sekundære effektmål er ændringer i:
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    Søvnkvalitet og varighed: Pittsburg søvnkvalitetsindeks, subjektive
    søvnkvalitet og varighedsdomæner Objektivt målt søvnvarighed og
    mønstre: Accelerometerdata
    Aktiviteter i dagligdagen: Evaluering af motoriske og process
    færdogheder og aktiviteter i den daglige leve-spørgeskema
    Livskvalitet: The EuroQol Group selvklassificerede
    sundhedsspørgeskema 5D
    Øvrige sekundære effektmål er ændringer i:
    Søvnforsinkelse: Pittsburg søvnkvalitetsindeks, subjektive
    søvnforsinkelsesdomæner Smerte self-efficacy:
    Det smerte-self-efficacy spørgeskema
    Stivhed: Fibromyalgi Effekt Spørgeskema-revideret, Stivheds skala
    Energiniveau: Fibromyalgi Impact Spørgeskema-revideret, energi skala
    Objektivt målt fysisk aktivitet: Accelerometer-data
    Udhvilethed: Fibromyalgi Impact-spørgeskema - revideret, udhvilet skala
    Depression: Fibromyalgi Impact Spørgeskema - revideret, depression -
    skala Depression, angst og stress:
    Depression, Angst og Stress skala
    Angstniveau: Fibromyalgi Impact Spørgeskema-revideret, angst skala
    Oplevet stress: Den Oplevede Stress Skala
    Kortisolkoncentration i hår: Hårklipningsanalyse
    Hukommelsesproblemer: Fibromyalgi Impact Spørgeskema-revideret,
    hukommelse skala Ømheds niveau (ømhed ved
    berøring): Fibromyalgi Impact Spørgeskema - revideret, ømhedsskala
    Balanceproblemer: Fibromyalgi Impact Spørgeskema - revideret, balance
    skala Overfølsomhed for lyd og lys og
    følsomhed: Fibromyalgi Impact Spørgeskema - revideret,
    sensitivitetsskala Tryk smertetærskel og tolerance: Tryk manchet
    algometri
    Appetit: Det forenklede ernæringsmæssige appetitspørgeskema
    Kropsvægt
    Kropssammensætning: Bioimpedans
    Kropsfedtfordeling: Talje og hofteomkretser
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to week 24
    Fra baseline til uge 24
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number 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.8.5The 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 Yes
    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 Visit Last subject
    Sidste besøg sidste deltager
    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 days
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state200
    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)
    None
    Ingen
    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 Decision2020-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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