The CanISleepinMS Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Wageningen Research Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

26 Mar 2024 → 28 Apr 2026

Decision date (initial)

2025-01-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Nationaal MS Fonds

External identifiers

EU CT number

2024-518280-35-00

EudraCT number

2022-002372-36

WHO UTN

U1111-1314-5572

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To investigate the effect of CBD on MS patients with impaired sleep quality.

Conditions and MedDRA coding

Insomnia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 26

1. A diagnosis of MS confirmed by a neurologist, based on the revised 2010 or 2017 McDonalds criteria
2. Relapsing-remitting or primary or secondary progressive MS
3. Expanded Disability Status Scale (EDSS) score < 7.5
4. No relapse for at least 6 months before the screening visit
5. 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)
6. Age minimally 18 years at the time of screening
7. 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
8. Elevated levels of transaminases (ALT, AST) until twice the Upper Limit of Normal (2x ULN) are allowed, as elevation of these levels is a common finding in MS patients.
9. No plans to (be involved in) getting pregnant during the trial.
10. No breast feeding during the trial
11. A complaint of chronic impairment of sleep quality, leading to a diagnosis of insomnia by an MS neurologist and an experienced somnologist
12. Continuation of pharmacological treatments will be at the discretion of the study physicians
13. Willing and able to refrain from new, sleep-facilitating pharmacological treatments until the end of the treatment phase of the study
14. Willing and able not to use any other cannabis product until completion of the study
15. Willing and able not to use any supplement that could promote sleep (e.g. L-tryptophan, valerian, melatonin) during the treatment phase of the study
16. Continuation of non-pharmacological treatments will be at the discretion of the study physicians
17. Willing and able to refrain from new, sleep-facilitating non-pharmaceutical interventions until the end of the treatment phase of the study. Lifestyle should be kept as stable as possible.
18. Willing and able to give informed consent
19. Willing and able to fill in a daily digital diary during the treatment 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 treatment phase of the study
20. Willing and able to use the Neurokeys app (thus mobile phone) daily
21. Willing to have blood sampled at the screening visit and have another two blood draws during the treatment phase of the study
22. 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 treatment phase of the study
23. Willing and able not to do evening/night shift work and not to cross time zones until the completion of the study
24. 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
25. Willing and able to refrain from (products of) grapefruit, Seville oranges (used in marmalade), limes and pomelos during the treatment 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
26. Willing and able to refrain from experimenting with timing and type of diet, and beverages during the treatment phase of the study. A participant’s dietary intake pattern should be kept as stable as possible during the treatment phase as there are numerous dietary components other than furanocoumarins that may influence CBD bioavailability

Exclusion criteria 13

1. 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
2. Good response to initial treatment for the assessed sleep disorder
3. Use of a benzodiazepine or other sleep medication, unless the patient has tapered off the sleep medication before the moment of inclusion
4. Liver disease or blood levels of transaminases (ALT, AST) above 3x ULN, as long-term administration of high doses of CBD may affect (although reversible) liver function
5. History of severe psychiatric comorbidity
6. Increased risk of suicidal thoughts or behaviour
7. History of drug or alcohol abuse
8. Known or suspected hypersensitivity to cannabinoids or to excipients of the formulation of the investigational product - almond oil
9. History of use with CBD oil prepared by Clinical Cannabis Care pharmacy
10. Structural or recreational use of a cannabinoid product < 2 months before screening
11. 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
12. 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
13. Drugs with risk of interaction with CBD. Data on the potential drug-CBD interactions below are based on mechanistic and clinical studies: 1) Drugs of which their biotransformation is primarily dependent on the cytochrome P450 enzymes CYP2C19 and CYP3A 2) Drugs that are inducers or inhibitors of enzymes of which CBD is a substrate: CYP2C19, CYP3A4.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Insomnia Severity Index (ISI) questionnaire

Secondary endpoints 4

1. Diary with sleep-related outcomes (Sleep Onset Latency (SOL), number of awakenings (NA), Wake time After Sleep Onset (WASO), Total Sleep Time (TST), and Sleep Efficiency (SE))
2. Daily recorded non-sleep outcomes are number of nocturnal voiding and potentially occurring adverse events (AEs).
3. Neurokeys app
4. The questionnaires ESS, FSS, and CIS-F

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Wageningen Research Stichting

Sponsor organisation

Wageningen Research Stichting

Address

Droevendaalsesteeg 4

City

Wageningen

Postcode

6708 PB

Country

Netherlands

Scientific contact point

Organisation

Wageningen Research Stichting

Contact name

Health research unit

Public contact point

Organisation

Wageningen Research Stichting

Contact name

Health research unit

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications