A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease
Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Colorado, Denver
Collaborators:
Colorado Department of Public Health and Environment GW Research Ltd