Trial · NCT03582137
A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease
NCT03582137, Phase 2, Completed, University of Colorado, Denver; results first posted 2024-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease. Trials, record NCT03582137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03582137
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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 Motor Symptoms in Parkinson's Disease
- NCT number
- NCT03582137
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Parkinson Disease
- Interventions
- Cannabidiol, Placebo
- First posted
- 2018-07-10
- Last updated
- 2024-07-23
- Results first posted
- 2024-07-23
Source ClinicalTrials.gov
Registered outcomes61
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores | 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. |
| Secondary | The Number of Participants Wtih Treatment-related Adverse Events | 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, anorexia, appetite changes, weight loss or gain, diarrhea, convulsion, abdominal pain, weakness, fever and other unexpected AEs. All of the these AEs will be recorded and counted. |
| Secondary | Change in Liver Function Monitoring --Liver Function Test | 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). |
| Secondary | The Number of Participants Wtih Liver Function Impairment Related Adverse Events | 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. |
| Secondary | Change in Blood Pressure (Systolic) | 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. |
| Secondary | Change in Vital Signs-heart Rate | Baseline; at the end of 2.5 mg/kg/day, through 3 weeks | The change may be Heart rate (beat/minute) while standing. |
| Secondary | Change in Vital Signs--weight | 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. |
| Secondary | Change in Vital Signs--temperature (Fahrenheit Degree) | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | The change may be temperature in Fahrenheit degree |
| Secondary | Change in Physical Exam | 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. |
| Secondary | Change in Neurological Exam | 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. |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 registered outcomesOutcomes61
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores | From baseline to the end of 2.5 mg/kg/day of CBD, through 3 weeks | units on a scale | MEAN | |
| SECONDARY | The Number of Participants Wtih Treatment-related Adverse Events | Every 3-5 days at each dose level, assessed up to 3 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Liver Function Monitoring --Liver Function Test | Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Participants Wtih Liver Function Impairment Related Adverse Events | Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Blood Pressure (Systolic) | Baseline; at the end of 2.5 mg/kg/day, through 3 weeks | change in mmHg | MEAN | |
| SECONDARY | Change in Vital Signs-heart Rate | Baseline; at the end of 2.5 mg/kg/day, through 3 weeks | change in beats per minute | MEAN | |
| SECONDARY | Change in Vital Signs--weight | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | change in kilograms | MEAN | |
| SECONDARY | Change in Vital Signs--temperature (Fahrenheit Degree) | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | change in degrees Fahrenheit | MEAN | |
| SECONDARY | Change in Physical Exam | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Neurological Exam | From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 outcomesResults by group134
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores | CBD Cannabis Extract Oral Solution | -4.5714 | 95% Confidence Interval -8.1126 to -1.0302 | units on a scale | |
| Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores | Placebo | -2.7665 | 95% Confidence Interval -4.9213 to -0.6118 | units on a scale | |
| The Number of Participants Wtih Treatment-related Adverse Events | CBD Cannabis Extract Oral Solution | 26 | Participants | ||
| The Number of Participants Wtih Treatment-related Adverse Events | Placebo | 25 | Participants | ||
| Change in Liver Function Monitoring --Liver Function Test | CBD Cannabis Extract Oral Solution | 0 | Participants | ||
| Change in Liver Function Monitoring --Liver Function Test | Placebo | 0 | Participants | ||
| The Number of Participants Wtih Liver Function Impairment Related Adverse Events | CBD Cannabis Extract Oral Solution | nausea | 6 | Participants | |
| The Number of Participants Wtih Liver Function Impairment Related Adverse Events | Placebo | nausea | 3 | Participants | |
| The Number of Participants Wtih Liver Function Impairment Related Adverse Events | CBD Cannabis Extract Oral Solution | diarrhea | 2 | Participants | |
| The Number of Participants Wtih Liver Function Impairment Related Adverse Events | Placebo | diarrhea | 4 | Participants |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CBD Cannabis Extract Oral Solution | 31 | |
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | COMPLETED | CBD Cannabis Extract Oral Solution | 30 | |
| Overall Study | COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | CBD Cannabis Extract Oral Solution | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events70
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 | Events |
|---|---|---|---|---|---|---|
| other | dizziness | Nervous system disorders | CBD Cannabis Extract Oral Solution | 18 | 31 | 18 |
| other | dizziness | Nervous system disorders | Placebo | 6 | 30 | 6 |
| other | feeling of relaxation | Nervous system disorders | CBD Cannabis Extract Oral Solution | 13 | 31 | 13 |
| other | feeling of relaxation | Nervous system disorders | Placebo | 7 | 30 | 7 |
| other | fatigue | Nervous system disorders | CBD Cannabis Extract Oral Solution | 10 | 31 | 10 |
| other | fatigue | Nervous system disorders | Placebo | 6 | 30 | 6 |
| other | decreased concentration | Nervous system disorders | CBD Cannabis Extract Oral Solution | 10 | 31 | 10 |
| other | decreased concentration | Nervous system disorders | Placebo | 4 | 30 | 4 |
| other | headache | Nervous system disorders | CBD Cannabis Extract Oral Solution | 9 | 31 | 9 |
| other | headache | Nervous system disorders | Placebo | 10 | 30 | 10 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CBD Cannabis Extract Oral Solution | 0 | 31 |
| Total, all-cause mortality | Placebo | 0 | 30 |
| Total, other adverse events | CBD Cannabis Extract Oral Solution | 26 | 31 |
| Total, other adverse events | Placebo | 25 | 30 |
| Total, serious adverse events | CBD Cannabis Extract Oral Solution | 1 | 31 |
| Total, serious adverse events | Placebo | 0 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38466972 | DERIVED |
Source PubMed
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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CBD Cannabis Extract Oral Solution vs Placebo: Difference in Proportion of Participants That Discontinue the Study Due to Study Drug Intolerance | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: Change in Liver Function Monitoring --Liver Function Test | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: Change in the Number of Participants With Presence of Seborrheic Dermatitis From Baseline to Final Visit. | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: Change in Laboratory Values--chemistry | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: Change in Neurological Exam | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: Change in Physical Exam | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: Change in Electrocardiograms | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: The Number of Participants Wtih Treatment-related Adverse Events | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: deaths from any cause | Trial comparisons |
| CBD Cannabis Extract Oral Solution vs Placebo: Change in Laboratory Values--hematology | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Line Angle Matching | Secondary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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.
GET https://conductscience.org/api/trials/v1/NCT03582137
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