CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
Cannabidiol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03582137
NCT03582137Phase 2Completed

A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease

University of Colorado, Denver·interventional·Posted Jul 10, 2018·Updated Jul 23, 2024

In Brief

A Phase 2 clinical trial evaluating Cannabidiol and Placebo for Parkinson Disease. Completed, enrolled 74 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 10, 2018
Enrollment StartSep 5, 2018
Primary CompletionJan 4, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.0 years ago

Interventions

Cannabidioldrug

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

Placeboother

Subjects randomized to this arm will receive Placebo