Tolerability and Efficacy of CBD Extract for RLS Treatment

Who can take part

• 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

Who cannot take part

• Currently on night shift work schedule
• 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
• Planned elective surgery during study participation
• Secondary RLS, such as Parkinson's disease or end-stage renal disease
• Present or past history of another severe sleep disorder
• 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
• 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
• History of drug or alcohol dependence
• Unstable medical condition
• Moderate or severe hepatic impairment
• Clinically significant laboratory abnormalities
• Current suicidal ideation
• Pending legal action or workers compensation
• Cannabis use (THC) detectable at the screening/baseline visits
• Is pregnant, lactating, or has a positive pregnancy test result pre-dose