The CanISleepinMS Study: Effect of Cannabidiol (CBD) on Sleep Quality in Patients With Multiple Sclerosis

NCT07840924 | Completed Phase 2 DMC

• 2 other identifiers: 61300340802024-518280-35-00
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the effect of 300 mg purified cannabidiol (CBD) on sleep quality in patients with multiple sclerosis (MS).

Conditions

Sleep Quality; Multiple Sclerosis; Insomnia

Keywords

Cannabidiol; Sleep; MS; Insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  The ISI is a validated tool to assess insomnia and sensitive to treatment response. The ISI is composed of seven items, each with a 5-point rating scale ranging between and to 4 (no to severe problem). Higher scores indicate worse outcomes. A total score between 0-7, 8-14, 15-21, and 22-28 is explained as no, sub threshold, moderate, and severe insomnia, respectively. A change in ISI score of 5 is considered as a clinical improvement.

  The ISI was administered at baseline and at the end of every treatment block, measuring perceived severity of insomnia over the last two weeks (weeks 2,5,9,13,17)

Secondary Outcomes (14)

• Sleep diary - total sleep time

  Daily; from enrollment to the end of treatment at 18 weeks, with an exception of wash out periods.

• Epworth Sleepiness Scale (ESS)

  At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)

• Fatigue Severity Scale (FSS)

  At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)

• Checklist Individual Strength Fatigue subscale (CIS-F)

  At the end of every two weeks in each of 4 treatment periods (weeks 1, 2, 4, 5, 8, 9, 12, 13, 16, 17)

• Keystroke dynamics

  Continuously and daily during the 18-week study period.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The investigational placebo consists of almond oil with a subtle blood orange flavor.

Drug: Cannabidiol Oil

Cannabidiol Oil

EXPERIMENTAL

The Investigational Medicinal Product consists of purified cannabidiol in almond oil.

Drug: Cannabidiol Oil

Interventions

Cannabidiol Oil DRUG

This study aims to compare the efficacy of CBD oil with a placebo to manage nocturnal sleep quality in MS patients.

Also known as: CBD

Cannabidiol Oil; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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 insomnia 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 treatment phase of the study

You may not qualify if:

• 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
• 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
• History of use with CBD oil prepared by pharmacy Clinical Cannabis Care
• Structural or recreational use of a cannabinoid product \< 2 months before screening
• 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.

Sponsors & Collaborators

• Wageningen University: lead
• Rijnstate Hospital: collaborator
• Sleep Medicine Centre Kempenhaeghe: collaborator
• Nationaal MS Fonds: collaborator

Study Sites (1)

Rijnstate

Arnhem, Netherlands

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Multiple Sclerosis

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Renger Witkamp, prof.dr.

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is a double blinded trial in which neither the participants nor the researcher knows when a participant receives cannabidiol or placebo.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr. Renger F. Witkamp (Emeritus Professor Nutritional Biology)

Model Details: A series of 16 N-of-1 trials; each N-of-1 trial will consist of a double crossover performed in a single patient. Within a crossover, the interventions with either CBD or placebo are randomised and double blinded. After a run-in period of 2 weeks, there will be 4 treatment periods of 3 weeks, separated from each other by a washout of 1 week.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start: March 26, 2024
• Primary Completion: March 28, 2026
• Study Completion: March 28, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

NL (1)