NL-OMON56335尚未招募2 期
The CanISleepinMS Study: Effect of cannabidiol (CBD) on sleep quality in patients with multiple sclerosis, a series of 15 randomised, placebo-controlled N-of-1 trials - Effect of CBD on sleep quality in MS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 • Willing and able not to use any other cannabis product
- •until completion of the study • 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. • Continuation of non-pharmacological treatments
- •will be at the discretion of the study physicians. • 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. • Willing and able to give informed consent • 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 • Willing and able to use the Neurokeys app (thus mobile phone) daily •
- •Willing to have blood sampled at the screening visit and have another two blood
- •draws during the treatment phase of the study • 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 • Willing and able
- •not to do evening/night shift work and not to cross time zones until the
- •completion of the study • 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 ev
排除标准
- •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 • Use of a benzodiazepine or other sleep medication, unless the
- •patient has tapered off the sleep medication before the moment of inclusion •
- •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 • 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. o 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. o 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.
研究者
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