At a glance
ClinicalIndex Comparison Record- ✓Age 45–78 years
- ✓Idiopathic Parkinson's disease by UK Brain Bank Clinical Diagnostic Criteria
- ✓Rest tremor amplitude score ≥2 in any limb on MDS-UPDRS question 3.17 (ON state)
- ✓Anti-parkinsonian medication unchanged for ≥1 month prior to study entry
- ✕Known or suspected allergy to cannabinoids or study drug excipients
- ✕Cannabinoid use in the previous 30 days
- ✕History of drug or alcohol dependence requiring inpatient treatment
- ✕Dopamine blockers within 180 days; amphetamine, cocaine, MAO-A inhibitors within 90 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease
In Brief
A Phase 2 clinical trial evaluating cannabidiol for Parkinson's Disease. Completed, enrolled 13 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material. A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties.