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    Summary
    EudraCT Number:2018-002315-98
    Sponsor's Protocol Code Number:MedicalcannabisMSSCI2018
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2018-07-09
    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 number2018-002315-98
    A.3Full title of the trial
    The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial
    Effekten af medicinsk cannabis på neuropatiske smerter og spasticitet hos patienter med MS og patienter med rygmarvsskade. Et multicenter nationalt placebo-kontrolleret studium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury.
    Effekten af medicin indeholdende cannabis produkter på nervesmerter og muskelstivhed hos patienter med multiple sklerose og hos patienter med rygmarvsskade.
    A.3.2Name or abbreviated title of the trial where available
    The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI
    Effekten af medicinsk cannabis på neuropatiske smerter og spasticitet hos patienter med MS og SCI
    A.4.1Sponsor's protocol code numberMedicalcannabisMSSCI2018
    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 SponsorAarhus Universitetshospital
    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 supportMinistry of Health
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus Universitetshospital
    B.5.2Functional name of contact pointNeurologi
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 165
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number457845 4222
    B.5.6E-mailkrissven@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 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 capsule 5 mg
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive nameCBD
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 No
    D.IMP: 2
    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 nameDronabinol capsule 2,5 mg
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDRONABINOL
    D.3.9.1CAS number 1972-08-3
    D.3.9.3Other descriptive nameTHC
    D.3.9.4EV Substance CodeSUB06407MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 No
    D.IMP: 3
    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 / Dronabinol capsule 5 mg+2,5 mg
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDRONABINOL
    D.3.9.1CAS number 1972-08-3
    D.3.9.3Other descriptive nameTHC
    D.3.9.4EV Substance CodeSUB06407MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive nameCBD
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 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 placeboCapsule
    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
    Central neuropathic pain and spasticity
    Centrale smerter og spasticitet
    E.1.1.1Medical condition in easily understood language
    Nerve pain and muscle stiffness related to a lesion in the central nervous system
    Nervesmerter og muskelstivhed relateret til læsion i centralnervesystemet
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10028335
    E.1.2Term Muscle spasticity
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077975
    E.1.2Term Central neuropathic pain
    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 evaluate the efficacy of the cannabinoids THC, CBD and a combination of CBD/THC on central neuropathic pain and spasticity in patients with multiple sclerosis and in patients with spinal cord injury
    At undersøge effekten af medicinsk cannabis på neuropatiske smerter og spasticitet hos hhv. patienter med MS og patienter med rygmarvsskade. Vi ønsker desuden at undersøge forskelle i effekten af THC, CBD og kombinationen af CBD og THC.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of the cannabinoids THC, CBD and a combination of CBD/THC on the quality of life, cognition, stress, sleep, ataxia, and to explore the side effects.
    We also want to study the Pharmacodynamic and pharmacokinetic of the study medications.
    Som sekundære effektparametre ønsker vi at undersøge effekten på livskvalitet, kognitive funktioner, stress, søvn, ataxi (ved MS) og bivirkninger ved de enkelte præparater.
    Vi ønsker også at undersøge farmakodynamik og farmakokinetik mhp. at opnå mere viden om blodkoncentration (terapeutisk niveau), virkningsvarighed og udskillelse ved specifik dosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Probable or definite neuropathic pain in more than three months with a mean baseline pain intensity NRS >3 and < 9 and/or spasticity severity NRS > 3.
    2) Stable disease (MS and SCI)
    3) Age ≥ 18 years
    4) Written Informed consent
    5) Reliable contraception for fertile women
    1) Sikker eller sandsynlig neuropatisk smerte i mere end 3 mdr. med en gennemsnitlig smerteintensitet i baselineperiode NRS >3 og NRS ≤ 9 og/eller sværhedsgrad af spasticitet (NRS >3)
    2) Stabil grundsygdom (for MS-patienterne betyder det, at der ikke har været attak indenfor den seneste måneder og at der ikke har været skift i forebyggende behandling de foregående 3 måneder)
    3) Alder ≥ 18 år
    4) Informeret samtykke foreligger
    5) Fertile kvinder skal være i pålidelig antikonception iht LMS retningslinjer og der skal foreligge negativ graviditetstest
    E.4Principal exclusion criteria
    1) Other pain conditions (e.g. diabetic neuropathy), which cannot be distinguished from central pain in MS and/or SCI
    2) Current treatment with opioids
    3) Severe Psychiatric disorder in patient or biological family (except well-treated depression)
    4) History of suicidal
    5) Pregnant or lactating women
    6) Significant impairment of liver or kidney.
    7) History of severe cardiovascular disease
    8) History of seizures or epilepsy
    9) Active Cancer disease
    10) Abuse of cannabinoids, alcohol or medication.
    11) There should not be use of cannabinoids 3 months before the study or during the study.
    1) Konkurrerende smertesygdomme (som diabetisk neuropati), som ikke kan skelnes fra patientens smerte pga. rygmarvsskade eller MS
    2) Opioid behandling (der ikke kan udtrappes)
    3) Tidligere eller nuværende psykiatrisk sygdom hos patient eller nærmeste biologiske familie, fraset velbehandlet depression
    4) Tidligere selvmordstruet
    5) Graviditet og amning
    6) Lever- og/eller nyreinsufficiens.
    7) Kardio-vaskulær sygdom (fraset velbehandlet hypertension)
    8) Tidligere krampeanfald, epilepsi
    9) Aktiv kræftsygdom
    10) Tidligere eller aktuel alkohol/medicin/stofmisbruger eller positiv urin screening
    11) Aktuel rekreativt cannabis brug eller brug indenfor 3 måneder
    12) Medicinsk cannabis ordineret indenfor 3 måneder
    E.5 End points
    E.5.1Primary end point(s)
    1) Mean pain intensity during the last week of active treatment compared with baseline (Diary, Numeric Rating Scale (NRS)).
    2) Mean severity of spasticity during the last week of active treatment compared with baseline (Diary, NRS 0-10).

    1) Smerteintensitet (neuropatisk smerte), gennemsnit af smertescoring i dagbog under de sidste 7 dages aktiv behandling (uge 6) sammenlignet med 7 dages baseline periode (NRS 0 -10)
    2) Grad af spasticitet, gennemsnit af scoring i dagbog under de sidste 7 dages aktiv behandling sammenlignet med den7 dages baselineperiode (NRS 0 -10).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Mean pain intensity and mean spasticity score are evaluated during the last week of treatment (week 6) (from the patient diary).

    Primære effektparametre vurderes gennem den sidste behandlingsuge (uge 6) (fra patient dagbog)

    E.5.2Secondary end point(s)
    1) Patient Global Impression of Change (PGIC)
    2) Quality of life (EQ-5D)
    3) Farmakodynamic /kinetic: Cmax, Cmin, Cave, AUC0-24, Tmax, Tmin
    1) Patient Global Impression of Change” (PGIC, 7-punkts skala fra meget forværret til meget forbedret)
    2) Livskvalitet (EQ-5D)
    3) Farmakodynamik /kinetik: De farmakokinetiske parametre: Cmax, Cmin, Cave, AUC0-24, Tmax, Tmin
    E.5.2.1Timepoint(s) of evaluation of this end point
    PGIC and EQ-5D: At last visit (visit 4) in the last week in stable treatment (week 6)

    Farmacodynamic/kinetic are evaluated in 24 hours in the stable period of treatment (week 3-6)
    PGIC and EQ-5D: Ved sidste besøg (visit 4) i sidste uge på stabil behandling (uge 6)

    Farmakodynamik/kintetik undersøges over 1 dgn i de 3 uger, hvor patienten er i stabil behandling (uge 3-6)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 trial4
    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 concerned15
    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
    End of Trial is when follow-up call to the last included subject has been completed
    Studiet anses som afsluttet, når der er foretaget telefonisk follow-up af den sidste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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: 368
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state448
    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 Decision2018-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-25
    P. End of Trial
    P.End of Trial StatusRestarted
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