MedTrace Logo

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

NCT03582137 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-07-23

Study results available
· View outcomes & findings →

Summary

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).

Conditions

  • Parkinson Disease

Interventions

DRUG

Cannabidiol

Subjects randomized to this arm will receive Cannabidiol Cannabis extract oral solution

OTHER

Placebo

Subjects randomized to this arm will receive Placebo

Sponsors & Collaborators

  • Colorado Department of Public Health and Environment

    collaborator OTHER_GOV

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Maureen Leehey · University of Colorado School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2022-01-04
Completion
2022-01-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582137 on ClinicalTrials.gov