The major purpose of the Stage 1 is to study the safety and tolerability of the proposed dosage regimen of the study drug. The form of cannabidiol (CBD) used in this study is GWP42003, supplied by GW Pharmaceuticals. The dosage regime is based on their experience. This is an open label study in 10 subjects, during which the dose is gradually increased to the manufacturers recommended target dose, with tolerability being evaluated at each dose level. Based on the response of subjects in the Stage 1, a target dose is determined for the next stage. Standardized tools will be administered to study both tolerability and efficacy. Efficacy assessments are simply explorative, and are done to look for an effect that warrants specific or different evaluation in the next stage.
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level
Timeframe: Every 3rd day on each dose level, assessed up to 5 weeks
Number of Participants Had Changes in Orthostatic Blood Pressure
Timeframe: Baseline and 5 weeks
Number of Participants Had Changes in Physical Exam
Timeframe: Baseline and 5 weeks
Number of Participants Had Changes in EKG
Timeframe: Baseline and 5 weeks
Number of Participants Had Changes in Laboratory Values
Timeframe: Baseline and 5 weeks
Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance
Timeframe: Baseline and 5 weeks
Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score
Timeframe: Baseline and 5 weeks
Change in Montreal Cognitive Assessment (MoCA)
Timeframe: Baseline and 5 weeks
Change in Anxiety Short Form
Timeframe: Baseline and 5 weeks
Change in Neuropsychiatric Inventory (NPI)
Timeframe: Baseline and 5 weeks
Change in Depression Short Form
Timeframe: Baseline and 5 weeks
Change in Scales for Outcomes in Parkinson's Disease (SCOPA)-Sleep-night Time Sleep
Timeframe: Baseline and 5 weeks
Change From Baseline of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
Timeframe: Baseline and 5 weeks
Change in Emotional and Behavioral Dyscontrol Short Form
Timeframe: Baseline and 5 weeks
Change in Pain Severity Form
Timeframe: Baseline and 5 weeks
Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)
Timeframe: Baseline and 5 weeks
Change in Fatigue Severity Scale
Timeframe: Baseline and 5 weeks
Change in International Restless Legs Syndrome Study Group Rating Scale for Restless
Timeframe: Baseline and 5 weeks
Change in Unified Dyskinesia Rating Scale (UDysRS)
Timeframe: Baseline and 5 weeks