Tolerability and Efficacy of CBD Extract for RLS Treatment

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)

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.

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:

1. Male or female subjects between 18 and 79 years of age, inclusive.
2. Willing and able to give informed consent.
3. Idiopathic RLS, meeting all 4 International RLS Study Group diagnostic criteria.
4. Moderate or severe symptoms, defined as an IRLS score ≥ 15 at screening visit.
5. RLS medications unchanged for 4 weeks prior to baseline.
6. 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.
7. Has a significant other, caregiver, or close acquaintance who knows the subject well and agrees to participate in the subject's neuropsychiatric assessment.
8. Agrees to not take more than 1 gram per day of acetaminophen.
9. 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:

1. Secondary RLS, such as Parkinson's disease or end-stage renal disease.
2. Present or past history of another severe sleep disorder.
3. Currently on night shift work schedule.
4. 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.
5. Current suicidal ideation.
6. Severe cognitive impairment (e.g., Alzheimer's Disease, traumatic brain injury).
7. Uncontrolled hypertension.
8. Known or suspected allergy or hypersensitivity to cannabinoids or excipients used in the study drug formulation.
9. Pending legal action or workers compensation.
10. Cannabis use (THC) detectable at the screening/baseline visits.
11. History of drug or alcohol dependence.
12. Use of dopamine blockers, cocaine, or MAO-A inhibitors within 90 days of baseline.
13. 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.
14. Unstable medical condition.
15. Clinically significant laboratory abnormalities.
16. Moderate or severe hepatic impairment.
17. Is pregnant, lactating, or has a positive pregnancy test result pre-dose.
18. Planned elective surgery during study participation.