Clinical Trials Register

Summary
EudraCT Number:	2020-004294-48
Sponsor's Protocol Code Number:	20200106
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-07-07
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

Netherlands - Competent Authority

A.2

EudraCT number

2020-004294-48

A.3

Full title of the trial

Glioma: Reducing Anxiety by conSuming cannabinoidS – GRASS study. Treating anxiety with CBD in glioma patients – A randomized-controlled trial

GRIP op spanning, bezorgdheid en piekeren, de GRASS studie. Cannabidiol voor het verminderen van klachten bij glioompatienten – een gerandomiseerde-gecontroleerde studie

A.3.1

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

GRASS study: Treating anxiety with CBD in glioma patients

GRASS studie: Cannabidiol voor het verminderen van spanning, bezorgdheid en piekeren bij hersentumorpatiënten

A.4.1

Sponsor's protocol code number

20200106

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	Amsterdam UMC, location VUmc
B.1.3.4	Country	Netherlands
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	Cancer Center Amsterdam
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Amsterdam UMC, location VUmc
B.5.2	Functional name of contact point	investigator
B.5.3	Address:
B.5.3.1	Street Address	Boelelaan 1117
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1081HV
B.5.3.4	Country	Netherlands
B.5.6	E-mail	v.belgers@amsterdamumc.nl

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	Arvisol
D.3.2	Product code	ECP015
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	cannabidiol
D.3.9.1	CAS number	13956-29-1
D.3.9.3	Other descriptive name	CANNABIDIOL
D.3.9.4	EV Substance Code	SUB26600
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	delta-9-tetrahydrocannabinol
D.3.9.3	Other descriptive name	DELTA-9-TETRAHYDROCANNABINOL
D.3.9.4	EV Substance Code	SUB27785
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	0.1
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	Yes
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	Yes
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

Primary brain tumor patients with anxiety symptoms

Hersentumorpatiënten met angstklachten

E.1.1.1

Medical condition in easily understood language

Brain tumor patients with anxiety symptoms

Patiënten met een hersentumor met angstklachten

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate the effect of a three-week treatment with cannabidiol (CBD) on anxiety in patients with a primary brain tumor that have no active oncological treatment.

Het effect van drie weken cannabidiol (CBD) op angstklachten in stabiele primaire hersentumorpatienten onderzoeken.

E.2.2

Secondary objectives of the trial

To investigate the effect of CBD on fatigue, depression and general quality of life in primary brain tumor patients that have no active oncological treatment

De effecten van CBD op vermoeidheid, depressieve klachten en algehele kwaliteit van leven in hersentumorpatiënten zonder actieve oncologische behandeling

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a. diagnosis of primary brain tumor;
b. ≥18 years of age;
c. moderate to severe anxiety, defined as S-STAI score ≥ 44 at baseline;
d. ability to understand and sign informed consent in Dutch;
e. stable disease, i.e. no oncological treatment for ≤2 months prior to inclusion;
f. no radiological progression on the most recent MRI, not older than 6 months, and no clinical progression within the most recent two months.

- diagnose van primaire hersentumor
- ≥18 jaar oud
- matige tot ernstige angstklachten, zoals gedefinieerd door een score van 44 of hoger op de S-STAI bij baseline
- vermogen om informed consent te begrijpen en ondertekenen in het Nederlands
- stabiele ziekte: geen oncologische behandeling in de afgelopen 2 maanden
- geen radiologische progressie op de meest recente MRI (<6 maanden gemaakt), geen klinische progressie in de afgelopen 2 maanden

E.4

Principal exclusion criteria

a. corticosteroid use, unless in a stable dose ≥ 8 weeks;
b. regular cannabis use currently or in past history (≤2 weeks);
c. substance abuse (defined as use of hard drugs, or alcohol use >3 units per day);
d. history of psychosis or anxiety disorder;
e. alterations in SSRI/SNRI use or dosage during the prior two months;
f. psychological or psychiatric treatment during the prior two months aimed at anxiety;
g. current pregnancy or have given birth less than three months ago;
h. currently breastfeeding;
i. KPS <70;
j. uncontrolled hyperthyroidism;
k. severe liver disorders (AST, ALT and/or gamma-GT more than three times the upper limit);
l. severe kidney disorders (eGFR<30).

- corticosteroid gebruik, tenzij in stabiele dosering gedurende minimaal 8 weken
- regelmatig huidig cannabisgebruik of in de afgelopen 2 weken
- middelen misbruik (harddrugs gebruik, of meer dan 3 eenheden alcohol/dag)
- psychose of angststoornis in de voorgeschiedenis
- veranderingen in SSRI/SNRI gebruik of dosering in de afgelopen 2 maanden
- psychologische of psychiatrische behandeling in de afgelopen 2 maanden gericht op angst
- huidige zwangerschap of bevallen in de afgelopen 3 maanden
- het geven van borstvoeding
- KPS <70
- hyperthyreoidie
- ernstige leverfunctiestoornissen (ASAT, ALAT en/of gamma-GT meer dan 3x de bovenwaarde)
- ernstige nierfunctiestoornissen (eGFR<30)

E.5 End points

E.5.1

Primary end point(s)

significant improvement of S-STAI

significante verbetering op de S-STAI

E.5.1.1

Timepoint(s) of evaluation of this end point

S-STAI will be measured at baseline and twice during every intervention period. So a total of six times (baseline, during intervention, after intervention, second baseline (after washout), during placebo and after placebo.

S-STAI wordt zes keer afgenomen, bij baseline, tijdens interventie, na interventie, bij tweede baseline (dus na washout), tijdens placebo en na placebo

E.5.2

Secondary end point(s)

Improvement on the following subjects:
· distress, depression, happiness;
· QoL and HRQoL;
· fatigue, sleep;
· cognitive complaints, performance status;
· control over life and impact on work;
· treatment-related outcomes;
· brain connectivity and network topology

verbetering van de volgende onderdelen:
- distress, depressie, geluk
- kwaliteit van leven
- vermoeidheid, slaap
- cognitieve klachten, functionele klachten
- controle over eigen leven en effect op werkzaamheden
- behandel-gerelateerde uitkomsten
- hersen netwerken en topologie

E.5.2.1

Timepoint(s) of evaluation of this end point

at baseline and at the end of each period (intervention and placebo) so four times in total

aan het begin en aan het einde van beide fases, dus vier keer in totaal

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

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

E.8.1.6

Cross over

Yes

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

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

LVLS

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:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

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

geen

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

2021-07-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-24

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

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