Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2019-002394-59

A.3

Full 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.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Medical Cannabis for Fibromyalgia

Medicinsk Cannabis for Fibromyalgi

A.4.1

Sponsor's protocol code number

P142

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	The Parker Institute, Bispebjerg and Frederiksberg Hospital
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	The Oak Fondation
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	The Danish Rheumatism Association
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Bispebjerg and Frederiksberg Internal research Grant
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Erna Hamilton Foundation
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Aase and Ejnar Danielsens foundation
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Nordic Cannabis Research
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Linnea Switzerland
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	The Parker Institute
B.5.2	Functional name of contact point	Marianne Uggen Rasmussen
B.5.3	Address:
B.5.3.1	Street Address	Nordre Fasanvej 57
B.5.3.2	Town/ city	Frederiksberg
B.5.3.3	Post code	2000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4538164197
B.5.5	Fax number	+4538164159
B.5.6	E-mail	marianne.uggen.rasmussen@regionh.dk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cannabidiol tablet 10 mg
D.3.2	Product code	None
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Fibromyalgia

Fibromyalgi

E.1.1.1

Medical condition in easily understood language

Chronic Widespread Pain

Kroniske generaliserede muskelsmerter

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10016631
E.1.2	Term	Fibromyalgia syndrome
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

From baseline to week 24

Fra baseline til uge 24

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial 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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

175

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

200

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-08-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-30

P. End of Trial
P.	End of Trial Status	Ongoing

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