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Cannabinoid

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

Phase 2
Recruiting
Led By Maureen Leehey
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks.

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).

Eligible Conditions
  • Dementia
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores
Secondary study objectives
Change From Baseline for the Delayed Recall Trials Score of HVLT-R
Change From Baseline in Hopkins Verbal Learning Test-Delayed Recognition Trial
Change in Anxiety Short Form Response
+57 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
29%
Tiredness
20%
Constipation
18%
Drowsiness
11%
Poor sleep
11%
Dizziness
9%
Poor Appetite
9%
Headache
4%
Nausea
4%
Itching
2%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
CBD Oil Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBD Cannabis extract oral solutionExperimental Treatment1 Intervention
Cannabidiol (CBD) Cannabis extract oral solution
Group II: placeboPlacebo Group1 Intervention
Placebo oral solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010

Find a Location

Who is running the clinical trial?

Colorado Department of Public Health and EnvironmentOTHER_GOV
10 Previous Clinical Trials
9,489 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,808 Previous Clinical Trials
2,822,165 Total Patients Enrolled
8 Trials studying Dementia
5,270 Patients Enrolled for Dementia
Maureen LeeheyPrincipal InvestigatorUniversity of Colorado School of Medicine
~10 spots leftby Dec 2025
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