Not yet recruiting NCT07224932

Tolerability and Efficacy of CBD Extract for RLS Treatment

Phase II Interventional Restless Leg Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: BRC-002, Placecbo.
Who it may be relevant to: Registry conditions: Restless Leg Syndrome. Basic parameters: 18 years — 79 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Detailed description

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.

Interventions

Drug BRC-002
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).
Drug Placecbo
Oral solution of mono-, di-, and triglycerides

Primary outcome measures

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. [Time frame: Baseline, Visit 3, Visit 4, Visit 5]

Secondary outcome measures (12)

To examine the effect of BRC-002 on RLS symptoms assessed through changes from baseline in RLS-6 Severity Scale [Time frame: 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) [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 on RLS symptoms assessed through changes in sleep quality index (SQI) as measured by the SleepImage Ring [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Pittsburgh Sleep Quality Index (PSQI). [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 in sleep measured by change in the Epworth Sleepiness Scale (ESS) [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Fatigue Severity Scale (FSS). [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 in cognition measured by change in the Montreal Cognitive Assessment (MoCA) [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 in psychiatric symptoms measured by change in the Neuropsychiatric Inventory (NPI) assessment. [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 in mood measured by change in the Emotional and Behavioral Dyscontrol Short Form. [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 on RLS symptoms assessed through changes in Patient Reported Outcome Measurement Information System (PROMIS). [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 in suicidality measured by change in the Columbia-Suicide Severity Rating Scale (C-SSRS). [Time frame: Baseline; Day 20]
To examine the effect of BRC-002 on RLS symptoms assessed through changes in Clinical Global Impression (CGI) Scales [Time frame: Baseline; Day 20]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07224932 · 23-0682

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗