CANnabidiol for Parkinson’s Disease Psychosis (CAN-PDP), version 1
Research type
Research Study
Full title
CANnabidiol for Parkinson’s Disease Psychosis (CAN-PDP)
IRAS ID
271052
Contact name
Sagnik Bhattacharyya
Contact email
Sponsor organisation
King's College London
Eudract number
2019-003623-37
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
Parkinson’s disease psychosis (PDP) refers to the range of illusions, hallucinations and delusions that occur in Parkinson’s disease. Their prevalence increases with illness duration, with most patients eventually developing such symptoms. Although there are some clinical options available for treating PDP, they are either not very effective or safe.
The purpose of this study is to test whether a new investigational medicine called cannabidiol (CBD) is safe and well tolerated in patients with PDP who will also be on other medications. It is also unclear which dose of CBD should be used. In order to meet our overarching aims, our study will consist of 2 phases.
The first phase is a multi-centre, open label, safety, tolerability and dose-finding study of CBD. CBD will be given orally, once per day for 6 weeks in different doses as per dosing protocol. We plan to investigate 5 dose levels (200mg-1000mg/day) in up to 24 participants. To identify the maximum tolerated dose (MTD) of orally administered CBD, we will employ a variation of the traditional 3+3 design, with subjects assigned in groups of 3 to each dose. For the purposes of this study, MTD will be determined by toxicity and defined as the highest dose at which less than 2 out of 6 patients at a specified dose level experience a drug-related dose-limiting toxicity.
The second phase is a multi-centre, randomised, double-blind, placebo-controlled trial of CBD versus placebo. Up to 120 eligible patients will be randomly assigned to receive CBD or matching placebo capsules for 12 weeks. Within the CBD arm, a single daily dose of CBD (dosage as identified from Phase I study) given in capsule form to be taken orally. The aim of the trial is to test the safety, tolerability and efficacy of CBD compared to matched placebo in people with PDP.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1967
Date of REC Opinion
20 Jan 2020
REC opinion
Further Information Favourable Opinion