Tolerability and Efficacy of CBD Extract for RLS Treatment

Conditions

• Restless Leg Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• 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).
• Placecbo — DRUG
  Oral solution of mono-, di-, and triglycerides

Study Details

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.

Key Dates

First listed

Nov 5, 2025

Start date

Nov 1, 2026

Status verified

Oct 2026

Primary completion

Mar 14, 2028

Completion

Jun 1, 2028

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• Experimental: BRC-002
  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.

Primary Outcome Measure

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 ]

Central Contacts

• Jacquelyn Bainbridge
  303-810-4254
  [email protected]

Locations (1)

Find similar trials in Aurora, CO