NCT03582137

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

Completed Phase 2 Results posted Last updated 23 July 2024

What this trial tests

Phase 2 trial testing Cannabidiol in Parkinson Disease in 74 participants. Completed in 4 January 2022.

Timeline

5 September 2018

Primary endpoint
4 January 2022

4 January 2022

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	74
Start date	5 September 2018
Primary completion	4 January 2022
Estimated completion	4 January 2022
Sites	1 location across United States

Drugs / interventions tested

• Cannabidiol (CANNABIDIOL) — full drug profile →
• Placebo

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

University of Colorado, Denver

Who can join

Adults 40 to 85, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores Primary · From baseline to the end of 2.5 mg/kg/day of CBD, through 3 weeks

Movement Disorders Society-Unified Parkinson's disease rating scale(MDS UPDRS) Part III assesses the motor signs of PD. There are 33 scores based on 18 items, several with right, left or other body distribution scores.Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The possible change may be the scores of the total 33 scores. Scores ranges 0 -132. Higher values represent a worse outcome.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	-4.5714	-8.1126 – -1.0302
Placebo	-2.7665	-4.9213 – -0.6118

The Number of Participants Wtih Treatment-related Adverse Events Secondary · Every 3-5 days at each dose level, assessed up to 3 weeks

Adverse events (AEs) are collected at each dose level. AEs collection include Serious Adverse Events (SAE), withdrawal symptoms and common AEs. SAE is an undesirable medical occurrence that results in death, or life-threatening, or inpatient hospitalization or prolongation of existing hospitalization or significant disability or incapacity or in a congenital anomaly/birth defect. Withdrawal and common AEs include headache, anxiety, nausea/vomiting, tremor, chills, decreased concentration, increased concentration, agitation, irritability, sleep disturbances, mood changes, somnolence, fatigue, a

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	26
Placebo	25

Change in Liver Function Monitoring --Liver Function Test Secondary · Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks.

Liver function tests will be performed and evaluated at each clinic visit from baseline through 3 weeks. The result is reported as the number of participants that had a clinically significant change in the values of the liver function test, including aspartate aminotransferase (AST), Alanine transaminase (ALT), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (Alk Phos), Total Bilirubin (TB).

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	0
Placebo	0

The Number of Participants Wtih Liver Function Impairment Related Adverse Events Secondary · Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks.

Liver function impairment will be evaluated and then related to adverse events and documented at each clinic visit. The change may be the frequency and severity of liver function impairment related AEs, including nausea/vomiting, diarrhea, abdominal pain, fatigue, weakness, chills, appetite changes, weight loss or gain, fever, etc.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	6
Placebo	3
CBD Cannabis Extract Oral Solution	2
Placebo	4
CBD Cannabis Extract Oral Solution	10
Placebo	6
CBD Cannabis Extract Oral Solution	1
Placebo	3

Change in Blood Pressure (Systolic) Secondary · Baseline; at the end of 2.5 mg/kg/day, through 3 weeks

Standing systolic blood pressure measurements will be assessed through 3 weeks. The change may be the value of systolic blood pressure.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	-5.4145	-11.4569 – 0.6279
Placebo	-0.9891	-6.4615 – 4.4833

Change in Vital Signs-heart Rate Secondary · Baseline; at the end of 2.5 mg/kg/day, through 3 weeks

The change may be Heart rate (beat/minute) while standing.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	0.9459	-3.1640 – 5.0559
Placebo	0.6326	-2.1185 – 3.3838

Change in Vital Signs--weight Secondary · From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks

The change may be weight in kilograms or lbs.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	0.07389	-0.2163 – 0.3641
Placebo	-0.07658	-0.4177 – 0.2645

Change in Vital Signs--temperature (Fahrenheit Degree) Secondary · From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks

The change may be temperature in Fahrenheit degree

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	-0.3069	-0.6335 – 0.01972
Placebo	-0.1882	-0.5579 – 0.1816

Change in Physical Exam Secondary · From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks

The result is reported as the number of participants that had a clinically significant change in the physical exam findings, including allergic immunologic, cardiovascular, constitutional symptoms, ENT, endocrine, eyes, gastrointestinal, genitourinary, hematologic, integumentary, musculoskeletal, neurological, psychiatric, respiratory and other symptoms clinical significant findings.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	0
Placebo	0

Change in Neurological Exam Secondary · From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks

The result is reported as the number of participants that had a clinically significant change in the general neurological exam clinical significant findings, including cranial nerves, motor strength, sensation, reflexes, gait, and other movements.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	0
Placebo	0

Change in Electrocardiograms Secondary · From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks

The result is reported as the number of participants that had a clinically significant change in the EKG.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	0
Placebo	0

Change in Laboratory Values--hematology Secondary · From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks

The result is reported as the number of participants that had a clinically significant change in the values of Hematology parameters, including RBC, WBC, HB, PLT, et al.

Group	Value	95% CI
CBD Cannabis Extract Oral Solution	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CBD Cannabis Extract Oral Solution

Serious: 1/31 (3%)

Deaths: 0/31

Placebo

Serious: 0/30 (0%)

Deaths: 0/30

Serious adverse events (1 terms)

Reaction	System	CBD Cannabis Extract Oral …	Placebo
pneumonia	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (34 terms — click to expand)

Reaction	System	CBD Cannabis Extract Oral …	Placebo
dizziness	Nervous system disorders	—	—
feeling of relaxation	Nervous system disorders	—	—
fatigue	Nervous system disorders	—	—
decreased concentration	Nervous system disorders	—	—
headache	Nervous system disorders	—	—
somnolence	Nervous system disorders	—	—
feeling abnormal	Nervous system disorders	—	—
feeling drunk	Nervous system disorders	—	—
nausea	Gastrointestinal disorders	—	—
confusion	Nervous system disorders	—	—
thinking abnormal	Nervous system disorders	—	—
disorientation	Nervous system disorders	—	—
dry mouth	General disorders	—	—
fall	General disorders	—	—
increased concentration	Nervous system disorders	—	—
weakness	General disorders	—	—
diarrhea	Gastrointestinal disorders	—	—
increased appetite	Metabolism and nutrition disorders	—	—
agitation	Nervous system disorders	—	—
elevated mood	Nervous system disorders	—	—
anorexia	Metabolism and nutrition disorders	—	—
anxiety	Nervous system disorders	—	—
insomnia	Nervous system disorders	—	—
abdominal pain	Gastrointestinal disorders	—	—
sleep disturbance	Nervous system disorders	—	—
weight loss	General disorders	—	—
cold	Respiratory, thoracic and mediastinal disorders	—	—
cough	Respiratory, thoracic and mediastinal disorders	—	—
depression	Nervous system disorders	—	—
constipation	Gastrointestinal disorders	—	—
chills	General disorders	—	—
irritability	Psychiatric disorders	—	—
urinary tract infection	Renal and urinary disorders	—	—
vomiting	Gastrointestinal disorders	—	—

Most-reported serious reactions: pneumonia.

Data from ClinicalTrials.gov NCT03582137 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.