A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT02818777 |
Recruitment Status :
Completed
First Posted : June 30, 2016
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Parkinson's Disease |
Intervention |
Drug: cannabidiol |
Enrollment | 13 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Cannabidiol |
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GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring). Started at 5 mg/kg/day and is increased by 2.5-5 mg/kg at 3-5 day intervals to a target dose of 20 mg/kg/day. cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material. A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties. |
Period Title: Overall Study | |
Started | 13 [1] |
Completed | 10 |
Not Completed | 3 |
Reason Not Completed | |
Adverse Event | 3 |
[1]
The number of baseline participants was 13.
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Arm/Group Title | Cannabidiol | |
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GWP42003-P oral solution, is purified cannabidiol (purity of ≥98%, 100 mg/ml cannabidiol in sesame oil with anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring). Started at 5 mg/kg/day and is increased by 2.5-5 mg/kg at 3-5 day intervals to a target dose of 20 mg/kg/day. cannabidiol: Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material. A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties. |
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Overall Number of Baseline Participants | 13 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 13 participants | |
68.15 (6.05) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | |
Female |
3 23.1%
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Male |
10 76.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | |
Hispanic or Latino |
0 0.0%
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Not Hispanic or Latino |
13 100.0%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
13 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 13 participants |
13 100.0%
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Name/Title: | Dr. Maureen Anne Leehey |
Organization: | University of Colorado |
Phone: | 303-724-2194 |
EMail: | maureen.leehey@ucdenver.edu |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02818777 |
Other Study ID Numbers: |
15-0929 |
First Submitted: | May 6, 2016 |
First Posted: | June 30, 2016 |
Results First Submitted: | October 23, 2018 |
Results First Posted: | February 19, 2019 |
Last Update Posted: | February 19, 2019 |