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)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Comparator
Half of the patients will be randomized to receive placebo orally. It is an oral solution of mono-, di-, and triglycerides
干预措施: Placecbo (Drug)
BRC-002
Half of patients will be randomized to receive oral investigational product. BRC-002 is a non-scheduled high cannabidiol cannabis extract (<0.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant.
干预措施: BRC-002 (Drug)
结局指标
主要结局
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.
时间窗: Baseline, Visit 3, Visit 4, Visit 5
Participant reports measures the frequency of adverse events. This will be done with open-ended questions during patient visits and phone calls. Abnormal vital signs (BP, HR, RR) at patient visits measures the frequency of participants with adverse events. BP over 130/80 mmHg indicates worse outcomes. Lower scores indicate worse outcomes. HR ranges from 60 to 100 bpm; Scores outside this range indicates worse outcomes. RR ranges from 12-20 bpm. Scores outside this range indicated worse outcomes. A neurological exam and routine physical exam will be preformed to examine adverse events. Abnormal findings will constitute as an adverse event. Labs (serum CBC w/ diff, serum CMP, urinalysis) will measure frequency of adverse events. Abnormal CBC w/diff, CMP, and urinalysis values will be determined by lab ranges.
次要结局
- To examine the effect of BRC-002 on RLS symptoms assessed through changes from baseline in RLS-6 Severity Scale(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)(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(Baseline; Day 20)
- To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Pittsburgh Sleep Quality Index (PSQI).(Baseline; Day 20)
- To examine the effect of BRC-002 in sleep measured by change in the Epworth Sleepiness Scale (ESS)(Baseline; Day 20)
- To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Fatigue Severity Scale (FSS).(Baseline; Day 20)
- To examine the effect of BRC-002 in cognition measured by change in the Montreal Cognitive Assessment (MoCA)(Baseline; Day 20)
- To examine the effect of BRC-002 in psychiatric symptoms measured by change in the Neuropsychiatric Inventory (NPI) assessment.(Baseline; Day 20)
- To examine the effect of BRC-002 in mood measured by change in the Emotional and Behavioral Dyscontrol Short Form.(Baseline; Day 20)
- To examine the effect of BRC-002 on RLS symptoms assessed through changes in Patient Reported Outcome Measurement Information System (PROMIS).(Baseline; Day 20)
- To examine the effect of BRC-002 in suicidality measured by change in the Columbia-Suicide Severity Rating Scale (C-SSRS).(Baseline; Day 20)
- To examine the effect of BRC-002 on RLS symptoms assessed through changes in Clinical Global Impression (CGI) Scales(Baseline; Day 20)
- To examine the effect of BRC-002 on RLS symptoms assessed through changes in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL).(Baseline; Day 20)