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Clinical trial

A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease

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Last updated:17th Sep 2018
Identifier: NCT03582137

The major purpose of this study is to assess the efficacy of CBD on motor symptoms of Parkinson's Disease (PD), and secondarily to study the safety and tolerability of CBD and other efficacy, particularly regarding tremor in PD. The study has been powered to detect a clinically significant reduction in Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor scores. This is a 1:1 parallel, double-blind, randomized controlled trial (RCT) with 60 participants. The investigators will be recruiting up to 75 participants; the goal is to have 60 participants (30 in CBD group and 30 in placebo group) complete the study. The study drug is obtained from the National Institute on Drug Abuse (NIDA).


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease
Actual Study Start Date: September 17, 2018
Estimated Primary Completion Date: December 2019
Estimated Study Completion Date: June 2020

Arms:
- Experimental:
CBD Cannabis extract oral solution
- Placebo Comparator: placebo

Category Value
Date last updated at source 2019-01-21
Study type(s) Interventional
Expected enrolment 75
Study start date 2018-09-17
Estimated primary completion date 2019-12-01

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