Tolerability and Efficacy of CBD Extract for RLS Treatment

Официальное название

A Randomized, Double-blind, Placebo-controlled Parallel Study of the Tolerability and Efficacy of High Cannabidiol (CBD) Cannabis Extract for the Treatment of Patients With Idiopathic Restless Legs Syndrome (RLS)

Обзор

This study plans to learn more about the safety and tolerability of high Cannabidiol (CBD) cannabis extract (BRC-002) for use in Idiopathic Restless Legs Syndrome. Symptoms and side effects experienced while taking the study drug will be tracked to determine if this medication is safe to use.

Подробное описание

This randomized, placebo-controlled clinical trial will evaluate the safety, tolerability, and therapeutic effects of a high-CBD botanical extract in patients with idiopathic RLS. The study will examine changes in symptom severity, sleep quality, mood, and daily functioning to determine whether cannabinoid-based therapy offers a viable alternative or adjunctive treatment for RLS. Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Вмешательства

• Препарат BRC-002
  BRC-002 is a non-scheduled cannabidiol (CBD) formulation (\<0.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant. BRC-002 is a high Cannabidiol Botanical extract (100 mg/mL).
• Препарат Placecbo
  Oral solution of mono-, di-, and triglycerides

Первичные конечные точки

• To examine the safety and tolerability of oral high CBD extract in idiopathic RLS assessed by frequency of adverse events which will be monitored by patient reported adverse events, vital signs, physical exam, and safety labs during study visits. [Срок оценки: Baseline, Visit 3, Visit 4, Visit 5]

Вторичные конечные точки (12)

• To examine the effect of BRC-002 on RLS symptoms assessed through changes from baseline in RLS-6 Severity Scale [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 on RLS symptoms assessed through changes from baseline in change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 on RLS symptoms assessed through changes in sleep quality index (SQI) as measured by the SleepImage Ring [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Pittsburgh Sleep Quality Index (PSQI). [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 in sleep measured by change in the Epworth Sleepiness Scale (ESS) [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Fatigue Severity Scale (FSS). [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 in cognition measured by change in the Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 in psychiatric symptoms measured by change in the Neuropsychiatric Inventory (NPI) assessment. [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 in mood measured by change in the Emotional and Behavioral Dyscontrol Short Form. [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 on RLS symptoms assessed through changes in Patient Reported Outcome Measurement Information System (PROMIS). [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 in suicidality measured by change in the Columbia-Suicide Severity Rating Scale (C-SSRS). [Срок оценки: Baseline; Day 20]
• To examine the effect of BRC-002 on RLS symptoms assessed through changes in Clinical Global Impression (CGI) Scales [Срок оценки: Baseline; Day 20]

Критерии участия

Критерии включения

• Male or female subjects between 18 and 79 years of age, inclusive.
• Willing and able to give informed consent.
• Idiopathic RLS, meeting all 4 International RLS Study Group diagnostic criteria.
• Moderate or severe symptoms, defined as an IRLS score ≥ 15 at screening visit.
• RLS medications unchanged for 4 weeks prior to baseline.
• Must have a driver or available transportation (including provided Uber vouchers) to drive them to and from study visits and for other transportation needs during the treatment period.
• Has a significant other, caregiver, or close acquaintance who knows the subject well and agrees to participate in the subject's neuropsychiatric assessment.
• Agrees to not take more than 1 gram per day of acetaminophen.
• Whereas applicable, agrees to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment.

Критерии исключения

• Secondary RLS, such as Parkinson's disease or end-stage renal disease.
• Present or past history of another severe sleep disorder.
• Currently on night shift work schedule.
• History or diagnosis of schizophrenia, bipolar or a psychotic disorder, severe depression, or any mental health illness that would compromise the safety of the participant.
• Current suicidal ideation.
• Severe cognitive impairment (e.g., Alzheimer's Disease, traumatic brain injury).
• Uncontrolled hypertension.
• Known or suspected allergy or hypersensitivity to cannabinoids or excipients used in the study drug formulation.
• Pending legal action or workers compensation.
• Cannabis use (THC) detectable at the screening/baseline visits.
• History of drug or alcohol dependence.
• Use of dopamine blockers, cocaine, or MAO-A inhibitors within 90 days of baseline.
• Use of any drugs with known interactions with cannabinoids (e.g., tolcapone, clopidogrel, felbamate, warfarin, barbiturates, benzodiazepines, niacin, nicotinamide, isoniazid, ketoconazole, clobazam, valproate, mTOR inhibitors) within 90 days of baseline.
• Unstable medical condition.
• Clinically significant laboratory abnormalities.
• Moderate or severe hepatic impairment.
• Is pregnant, lactating, or has a positive pregnancy test result pre-dose.
• Planned elective surgery during study participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07224932 · 23-0682

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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