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    Summary
    EudraCT Number:2022-002372-36
    Sponsor's Protocol Code Number:2022-16039
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-09-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-002372-36
    A.3Full title of the trial
    The CanISleepinMS Study: Effect of cannabidiol (CBD) on sleep quality in patients with multiple sclerosis, a series of 15 randomised, placebo controlled N-of-1 trials
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of CBD on sleep quality in MS
    A.4.1Sponsor's protocol code number2022-16039
    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 SponsorWageningen Research Stichting
    B.1.3.4CountryNetherlands
    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 supportNationaal MS Fonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWageningen Research Stichting
    B.5.2Functional name of contact pointHuman Research Unit
    B.5.3 Address:
    B.5.3.1Street AddressDroevendaalsesteeg 4
    B.5.3.2Town/ cityWageningen
    B.5.3.3Post code6708 PB
    B.5.3.4CountryNetherlands
    B.5.6E-mailhru@wur.nl
    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 nameClinican CBD 10% oil
    D.3.4Pharmaceutical form Oromucosal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Oromucosal 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) 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 Yes
    D.3.11.13.1Other medicinal product typeCannabidiol
    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 liquid
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOromucosal liquid
    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
    Insomnia
    E.1.1.1Medical condition in easily understood language
    Impaired sleep quality
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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 investigate the effect of CBD on impaired sleep quality in MS patients.
    E.2.2Secondary objectives of the trial
    To investigate the effect of CBD in MS patients on: Diary measurements (sleep-related outcomes: number of awakenings (NA), Sleep Onset Latency (SOL), Sleep Efficiency (SE), Wake time After Sleep Onset (WASO), Total Sleep Time (TST); non-sleep outcomes: changes in number of nocturnal voidings, number, type, and
    severity of adverse events (AEs); Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), Checklist Individual Strength Fatigue-subschaal (CIS-F); Keystroke features of the Neurocast® App, a 24/7 digital measure of fatigue, rest and activity patterns, and daily functioning based on dynamics of keyboard
    key strokes on personal smartphones; furthermore answers on daily pop-up questions for Numeric Rating Scale (NRS) scores for pain, spasms, and fatigue.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A diagnosis of MS confirmed by a neurologist, based on the revised 2010 or 2017 McDonalds criteria Relapsing-remitting or primary or secondary progressive MS
    Expanded Disability Status Scale (EDSS) score < 7.5
    No relapse for at least 6 months before the screening visit
    No changes in immunomodulating therapy stable for at least 3 months
    before the screening visit; no changes in use of other medications used
    for chronic conditions for at least 6 weeks before the screening visit
    (e.g. anti-depressant drugs, antidiabetics)
    Age minimally 18 years at the time of screening
    Body Mass Index (BMI) < 35.0 kg/m2 at the moment of screening. BMI
    is used as a proxy for a participant's fat content; as CBD accumulates in fatty tissue, a higher fat content may prolong the elimination half-life
    of CBD.
    Elevated levels of transaminases (ALAT, ASAT) until twice the Upper
    Limit of Normal (2x ULN) are allowed, as elevation of these levels is a
    common finding in MS patients. These levels are monitored because
    CBD (long term administration of high doses) may affect (reversibly)
    liver function,
    No plans to (be involved in) getting pregnant during the trial.
    No breast feeding during the trial
    A complaint of chronic impairment of sleep quality, leading to a
    diagnosis of insomnia by an MS neurologist and an experienced
    somnologist. In this context, insomnia is defined as difficulties
    initiating and/or maintaining sleep or too early awakenings, despite
    adequate opportunity and circumstances for sleep, resulting in some
    form of daytime impairment. Causes include psychophysiological
    insomnia, insomnia due to mental disorders like depression, and
    insomnia secondary to other MS-related symptoms like spasticity, pain
    or nocturnal voidings. Diagnosis will be based on fulfilment of the
    ICDS-3 criteria of insomnia36 and an ISI score of minimally 15
    (threshold for clinical insomnia).
    Continuation of pharmacological treatments will be at the discretion of
    the study physicians.
    Willing and able to refrain from new, sleep-facilitating pharmacological
    treatments until the end of the intervention phase of the study
    Willing and able not to use any other cannabis product until completion
    of the study
    Willing and able not to use any supplement that could promote sleep
    (e.g. L-tryptophan, valerian, melatonin) during the intervention phase
    of the study.
    Continuation of non-pharmacological treatments will be at the
    discretion of the study physicians.Willing and able to refrain from new,
    sleep-facilitating nonpharmaceutical
    interventions until the end of the intervention phase of
    the study. Lifestyle should be kept as stable as possible.
    Willing and able to give informed consent.
    Willing and able to fill in a daily digital diary during the intervention
    phase, to send this to the study nurse or research assistant once a
    week, and to be contacted by the research assistant minimally twice a
    week during the intervention phase of the study
    Willing and able to use the Neurokeys app (thus mobile phone) daily
    Willing to have blood sampled at the screening visit and have another
    two blood draws during the intervention phase of the study
    Willing and able not to drive a car or operate machinery within 8 hours
    after intake of the investigational product until the end of the
    intervention phase of the study
    Willing and able not to do evening/night shift work and not to cross
    time zones until the completion of the study
    Willing and able to refrain from excessive use of excessive use of
    caffeine (> 1 cup of coffee or 1 serving of energy drink) and alcohol (>
    1 serving) in the evening, 6 hours before going to bed
    Willing and able to refrain from (products of) grapefruit, Seville
    oranges (used in marmalade), limes and pomelos during the
    intervention phase of the study. These citrus fruits contain
    furanocoumarins which irreversibly inhibit CYP3A4 enzymes. Sweet
    oranges as navel or Valencia do not inhibit CYP3A4 activity.
    Willing and able to refrain from experimenting with timing and type of
    diet, and beverages during the intervention phase of the study. A
    participant's dietary intake pattern should be kept as stable as possible
    during the intervention phase as there are numerous dietary
    components other than furanocoumarins that may influence CBD
    bioavailability.
    E.4Principal exclusion criteria
    A potential participant who meets any of the following criteria will be
    excluded from participation, unless the study physicians decide
    otherwise:
    Circadian rhythm sleep-wake disorders, sleep related breathing
    disorders (such as moderate to severe obstructive sleep apnea, central
    breathing disorders during sleep, or sleep-related stridor that require
    prompt specific treatment), current delayed sleep phase syndrome
    where wake up time is regularly later than 8.00 a.m., or a sleep
    problem fulfilling the ICSD3 criteria of parasomnias
    Good response to initial treatment for the assessed sleep disorder
    Use of a benzodiazepine or other sleep medication, unless the patient
    has tapered off the sleep medication before the moment of inclusion
    Liver disease or blood levels of transaminases (ALAT, ASAT) above 3x
    ULN, as long term administration of high doses of CBD may affect
    (although reversible) liver function.
    History of severe psychiatric comorbidity. Increased risk of suicidal
    thoughts or behaviour
    History of drug or alcohol abuse
    Known or suspected hypersensitivity to cannabinoids or to excipients
    of the formulation of the investigational product - almond oil
    Structural or recreational use of a cannabinoid product < 2 months
    before screening
    Whether the use of any of the following medications is a reason for
    exclusion will be at the discretion of the study physicians and delivery
    pharmacist.
    drugs with risk of liver injury; the decision of exclusion will be made in
    consultation with the MS neurologists and the pharmacist that provides
    the CBD product.
    drugs with risk of interaction with CBD. Data on the potential drug-CBD
    interactions below are based on mechanistic and clinical studies
    Drugs of which their biotransformation is primarily dependent on the
    cytochrome P450 enzymes CYP2C19 and CYP3A
    Drugs that are inducers or inhibitors of enzymes of which CBD is a
    substrate: CYP2C19, CYP3A4.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: Insomnia Severity Index (ISI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 2,6,10,14,18
    E.5.2Secondary end point(s)
    Secondary endpoints: diary measurements (sleep-related outcomes:
    number of awakenings (NA), Sleep Onset Latency (SOL), Sleep
    Efficiency (SE), Wake time After Sleep Onset (WASO), Total Sleep Time
    (TST); non-sleep outcomes: changes in number of nocturnal voidings,
    score of Numeric Rating Scale (NRS) for pain, score of NRS for spasms;
    score of NRS for fatigue; number, type, and severity of adverse events
    (AEs); Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS),
    Checklist Individual Strength Fatigue subscale (CIS-F), and keystroke
    dynamics features of the Neurokeys App, which continuously collects
    data from participants' interactions with their personal smartphone to
    assess measures such as fatigue, rest-activity patterns, and clinical
    status.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weekly; Neurokeys app 24/7.
    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 No
    E.6.5Efficacy No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Cross-over N-of-1 Trials
    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 trial1
    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 concerned3
    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
    When all participant data collected during the intervention phase of the trial (18 weeks total) is entered and checked in the data management system Castor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state15
    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)
    If an individual participant refrains from further participation, he or she will be followed up for a period of 2 weeks -or longer if considered necessary- by the trial clinicians or other clinician(s) in charge of follow-up.
    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 Decision2024-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-11-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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