Tolerability and Efficacy of CBD Extract for RLS Treatment

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.