Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT07224932
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT07224932
Study Brief:
Protocol Section:
NCT07224932