Trial · NCT02818777

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

NCT02818777, Phase 2, Completed, University of Colorado, Denver; results first posted 2019-02-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease. Trials, record NCT02818777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02818777

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease
NCT number: NCT02818777
Status: Completed
Phases: Phase 2
Enrollment: 13 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Parkinson's Disease
Interventions: cannabidiol
First posted: 2016-06-30
Last updated: 2019-02-19
Results first posted: 2019-02-19

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Every 3rd day on each dose level, assessed up to 5 weeks	Severity of each specific adverse event was scored as 0=no adverse event, 1=mild adverse event, 2=moderate adverse event, and 3=sever adverse event. The range of severity is 0-3. Higher scores mean a worse outcome. The severity was expressed as mean (standard deviation).
Primary	Number of Participants Had Changes in Orthostatic Blood Pressure	Baseline and 5 weeks	Orthostatic blood pressure will be monitored at each study visit.
Primary	Number of Participants Had Changes in Physical Exam	Baseline and 5 weeks	A physical exam will be performed at each study visit.
Primary	Number of Participants Had Changes in EKG	Baseline and 5 weeks	EKG will be performed at each study visit.
Primary	Number of Participants Had Changes in Laboratory Values	Baseline and 5 weeks	Laboratory tests (hematology, serum chemistry, and urinalysis) will be evaluated at each study visit.
Primary	Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance	Baseline and 5 weeks	Assessing the proportion of subjects that drop out of the study due to study drug intolerance.
Primary	Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score	Baseline and 5 weeks	There are four parts: Part I (Non-motor experiences of daily living, scores range 0-52), Part II (motor experiences of daily living, scores range 0-52), Part III (motor examination, scores range 0-132) and Part IV (motor complications scores range 0-24). Subscales are summed to a total score, ranging 0-260. Higher scores mean a worse outcome.
Primary	Change in Montreal Cognitive Assessment (MoCA)	Baseline and 5 weeks	MoCA - is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual -constructional skills, conceptual thinking, calculation. Scores range 0-30. Higher values represent a better outcome.
Primary	Change in Anxiety Short Form	Baseline and 5 weeks	This includes 8 items that assess severity of anxiety. Scores range 8-40. Higher values represent a worse outcome.
Primary	Change in Neuropsychiatric Inventory (NPI)	Baseline and 5 weeks	Assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders. It has proven to be sensitive to change and has been employed to capture treatment related behavioral.Total NPI scores range 0-120. Higher values represent a worse outcome.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Every 3rd day on each dose level, assessed up to 5 weeks	13 PD patients were included in safety analysis group because they were all treated with study drug.	units on a scale	MEAN
PRIMARY	Number of Participants Had Changes in Orthostatic Blood Pressure	Baseline and 5 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Had Changes in Physical Exam	Baseline and 5 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Had Changes in EKG	Baseline and 5 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Had Changes in Laboratory Values	Baseline and 5 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance	Baseline and 5 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score	Baseline and 5 weeks	10 Participants completed the study drug treatment and were included in the efficacy analysis group.	score on a scale	MEAN
PRIMARY	Change in Montreal Cognitive Assessment (MoCA)	Baseline and 5 weeks	10 Participants completed the study drug treatment and were included in efficacy analysis group.	score on a scale	MEAN
PRIMARY	Change in Anxiety Short Form	Baseline and 5 weeks	10 participants completed the study drug treatment and were included in efficacy analysis group.	score on a scale	MEAN
PRIMARY	Change in Neuropsychiatric Inventory (NPI)	Baseline and 5 weeks		score on a scale	MEAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group97

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 5 mg/kg/Day	Somnolence	1	Standard Deviation 0	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 7.5 mg/kg/Day	Somnolence	1	Standard Deviation 0	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 10 mg/kg/Day	Somnolence	1	Standard Deviation 0	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 15 mg/kg/Day	Somnolence	1.25	Standard Deviation 0.5	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 20 mg/kg/Day	Somnolence	1.143	Standard Deviation 0.345	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 25 mg/kg/Day	Somnolence	1.25	Standard Deviation 0.5	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 5 mg/kg/Day	Fatigue	1	Standard Deviation 0	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 7.5 mg/kg/Day	Fatigue	1	Standard Deviation 0	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 10 mg/kg/Day	Fatigue	1	Standard Deviation 0	units on a scale
Severity of Participants Reporting Study-related Adverse Events at Each Dose Level	Cannabidiol 15 mg/kg/Day	Fatigue	1.667	Standard Deviation 0.577	units on a scale

1 to 10 of 97Source ClinicalTrials.gov

See all 97 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cannabidiol	13
Overall Study	COMPLETED	Cannabidiol	10
Overall Study	NOT COMPLETED	Cannabidiol	3

Source ClinicalTrials.gov

Adverse events19

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	Cannabidiol	11	13
other	Somnolence	Nervous system disorders	Cannabidiol	9	13
other	Fatigue	General disorders	Cannabidiol	8	13
other	Weight gain	Metabolism and nutrition disorders	Cannabidiol	4	13
other	Abdominal pain	Gastrointestinal disorders	Cannabidiol	3	13
other	Dizziness	Nervous system disorders	Cannabidiol	3	13
other	weight loss	Metabolism and nutrition disorders	Cannabidiol	2	13
other	nausea	Gastrointestinal disorders	Cannabidiol	2	13
other	anorexia	Gastrointestinal disorders	Cannabidiol	2	13
other	increased appetite	Gastrointestinal disorders	Cannabidiol	2	13

1 to 10 of 19Source ClinicalTrials.gov

See all 19 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cannabidiol	0	13
Total, other adverse events	Cannabidiol	13	13
Total, serious adverse events	Cannabidiol	0	13

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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