Tolerability and Efficacy of CBD Extract for RLS Treatment | NCT07224932

NCT07224932

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Biopharmaceutical Research Company	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo Comparator	Placebo Comparator	Half of the patients will be randomized to receive placebo orally. It is an oral solution of mono-, di-, and triglycerides	Drug: Placecbo
BRC-002	Experimental	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.	Drug: BRC-002

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BRC-002	Drug	BRC-002 is a non-scheduled cannabidiol (CBD) formulation (<0.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant. BRC-002 is a high Cannabidiol Botanical extract (100 mg/mL).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	Baseline, Visit 3, Visit 4, Visit 5

Secondary Outcomes

Measure	Description	Time Frame
To examine the effect of BRC-002 on RLS symptoms assessed through changes from baseline in RLS-6 Severity Scale	The RLS-6 Severity Scale ranges from 0-60; increasing scores indicates a worse outcome.	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)

Eligibility Module

Eligibility Criteria

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.

ID	Term
D012148	Restless Legs Syndrome
D002189	Marijuana Abuse