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
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
Treatments tested in this trial
- BRC-002
- Placecbo
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
Biopharmaceutical Research Company
Collaborator
Source ClinicalTrials.gov