Health TrialsbyHealthPanel

Tolerability and Efficacy of CBD Extract for RLS Treatment

ConditionRestless Leg Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Placebo ComparatorPlacebo comparator 1 intervention
Group B: BRC-002Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Visit 3, Visit 4, Visit 5

Secondary outcomes

1

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)

The International Restless Legs Syndrome Study Group Rating Scale (IRLS) measures RLS symptoms. Scores range from 0 to 40, with higher scores indicating a worse outcome.

Time frame
Baseline; Day 20
2

To examine the effect of BRC-002 on RLS symptoms assessed through changes in sleep quality index (SQI) as measured by the SleepImage Ring

The SleepImage Recorder ring measures quality of sleep. Scores range from 0 to 100, with higher scores indicating a better outcome.

Time frame
Baseline; Day 20
3

To examine the effect of BRC-002 in sleep measured by change in the Epworth Sleepiness Scale (ESS)

The Epworth Sleepiness Scale (ESS)measures daytime sleepiness. Scores range from 0 to 24, with higher scores indicating a worse outcome.

Time frame
Baseline; Day 20
4

To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Fatigue Severity Scale (FSS).

The Fatigue Severity Scale (FSS) measures fatigue. Scores range from 9 to 63, with higher scores indicating a worse outcome.

Time frame
Baseline; Day 20

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Biopharmaceutical Research Company

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: