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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02818777
Recruitment Status : Completed
First Posted : June 30, 2016
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Collaborators:
Colorado Department of Public Health and Environment
GW Research Ltd
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design 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
Hide Arm/Group Description

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.
Arm/Group Title Cannabidiol
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
68.15  (6.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
3
  23.1%
Male
10
  76.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
13
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
1.Primary Outcome
Title Severity of Participants Reporting Study-related Adverse Events at Each Dose Level
Hide Description 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).
Time Frame Every 3rd day on each dose level, assessed up to 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
13 PD patients were included in safety analysis group because they were all treated with study drug.
Arm/Group Title Cannabidiol 5 mg/kg/Day Cannabidiol 7.5 mg/kg/Day Cannabidiol 10 mg/kg/Day Cannabidiol 15 mg/kg/Day Cannabidiol 20 mg/kg/Day Cannabidiol 25 mg/kg/Day
Hide Arm/Group Description:

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).

Dosage: 5 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.

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).

Dosage: 7.5 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.

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).

Dosage: 10 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.

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).

Dosage: 15 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.

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).

Dosage: 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.

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).

Dosage: 25 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.

Overall Number of Participants Analyzed 13 8 12 10 8 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Somnolence 1  (0) 1  (0) 1  (0) 1.25  (0.5) 1.143  (0.345) 1.25  (0.5)
Fatigue 1  (0) 1  (0) 1  (0) 1.667  (0.577) 1.25  (0.5) 1  (0)
Weight gain 1.333  (0.577) 0  (0) 1  (0) 1  (0) 1  (0) 0  (0)
increased appetite 1  (0) 0  (0) 0  (0) 1  (0) 0  (0) 0  (0)
Diarrhea 1  (0) 1  (0) 1  (0) 1.667  (0.842) 1  (0) 1.4  (0.775)
Weight loss 0  (0) 1  (0) 0  (0) 1  (0) 0  (0) 0  (0)
Abdominal pain 0  (0) 0  (0) 1  (0) 1  (0) 0  (0) 1  (0)
Nausea 0  (0) 0  (0) 1  (0) 2  (0) 1  (0) 0  (0)
Diziness 0  (0) 0  (0) 1  (0) 1  (0) 1  (0) 0  (0)
Weakness 0  (0) 0  (0) 1  (0) 2  (0) 0  (0) 0  (0)
Anorexia 0  (0) 0  (0) 0  (0) 2  (0) 0  (0) 2  (0)
Vomiting 0  (0) 0  (0) 0  (0) 0  (0) 1  (0) 0  (0)
Fever 0  (0) 0  (0) 0  (0) 0  (0) 0  (0) 1  (0)
2.Primary Outcome
Title Number of Participants Had Changes in Orthostatic Blood Pressure
Hide Description Orthostatic blood pressure will be monitored at each study visit.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Primary Outcome
Title Number of Participants Had Changes in Physical Exam
Hide Description A physical exam will be performed at each study visit.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Primary Outcome
Title Number of Participants Had Changes in EKG
Hide Description EKG will be performed at each study visit.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Primary Outcome
Title Number of Participants Had Changes in Laboratory Values
Hide Description Laboratory tests (hematology, serum chemistry, and urinalysis) will be evaluated at each study visit.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
5
  38.5%
6.Primary Outcome
Title Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance
Hide Description Assessing the proportion of subjects that drop out of the study due to study drug intolerance.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
3
  23.1%
7.Primary Outcome
Title Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score
Hide Description 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.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-7.70  (9.393)
8.Primary Outcome
Title Change in Montreal Cognitive Assessment (MoCA)
Hide Description 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.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.0  (1.491)
9.Primary Outcome
Title Change in Anxiety Short Form
Hide Description This includes 8 items that assess severity of anxiety. Scores range 8-40. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 participants completed the study drug treatment and were included in efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.33  (3.5668)
10.Primary Outcome
Title Change in Neuropsychiatric Inventory (NPI)
Hide Description 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.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.125  (1.5526)
11.Primary Outcome
Title Change in Depression Short Form
Hide Description This includes 8 items that assess severity of depression. Score range 8-40. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.85  (3.132)
12.Primary Outcome
Title Change in Scales for Outcomes in Parkinson’s Disease (SCOPA)-Sleep-night Time Sleep
Hide Description A valid, reliable, short scale that is used to evaluate night time sleep problems in PD. Scores range 0-18. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.80  (3.91)
13.Primary Outcome
Title Change From Baseline of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
Hide Description 10-item, patient self-rating instrument assessing the subject’s sleep behavior with short questions that have to be answered by either “yes” or “no”. Scores range 0-13. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.7  (1.767)
14.Primary Outcome
Title Change in Emotional and Behavioral Dyscontrol Short Form
Hide Description 8 items that assess severity of emotional and behavioral dyscontrol. Scores range 8-40. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-4.69  (6.144)
15.Primary Outcome
Title Change in Pain Severity Form
Hide Description This will assess severity of pain. Scores range 3-15. Higher scores represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.86  (4.711)
16.Primary Outcome
Title Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease-Rating Scale (QUIP-RS)
Hide Description To measure severity of symptoms and support a diagnosis of impulse control disorders and related disorders in PD. Total QUIP-RS scores were summed by 6 subscores (gambling 0-16, Sex 0-16, Buying 0-16, Eating 0-16, Hobbyism-punding 0-32, and PD Medication use 0-16), range 0-112. Higher scores represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
0  (0)
17.Primary Outcome
Title Change in Fatigue Severity Scale
Hide Description A self-report 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. Scores range 9-63. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.5  (11.4625)
18.Primary Outcome
Title Change in International Restless Legs Syndrome Study Group Rating Scale for Restless
Hide Description This encompasses a ten-question instrument for measuring severity of restless legs syndrome (RLS). Score range 0-40. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.2  (4.517)
19.Primary Outcome
Title Change in Unified Dyskinesia Rating Scale (UDysRS)
Hide Description To evaluate involuntary movements often associated with treated Parkinson’s disease. Total UDysRS scores is the sum of historical sub-scores (0-60) and objective sub-score (0-44). Total scores range 0-104. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.0  (3.887)
20.Secondary Outcome
Title Change in MDS-UPDRS Tremor Score (Total of Items 3.17 and 3.18) in the ON State
Hide Description Sum of items 3.17 and 3.18 of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates the rest tremor amplitude (3.17, score range 0-20) and constancy of rest tremor (3.18 score range 0-4). The sum scores of 3.17 and 3.18 range 0-24. Higher values represent a worse outcome.
Time Frame Baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
10 Participants completed the study drug treatment and were included in the efficacy analysis group.
Arm/Group Title Cannabidiol
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.4  (1.2649)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cannabidiol
Hide Arm/Group Description

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.

All-Cause Mortality
Cannabidiol
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cannabidiol
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cannabidiol
Affected / at Risk (%)
Total   13/13 (100.00%) 
Gastrointestinal disorders   
Diarrhea * 1  11/13 (84.62%) 
Abdominal pain * 1  3/13 (23.08%) 
nausea * 1  2/13 (15.38%) 
anorexia * 1  2/13 (15.38%) 
increased appetite * 1  2/13 (15.38%) 
vomiting * 1  1/13 (7.69%) 
flatulence * 1  1/13 (7.69%) 
gastroesophageal reflux * 1  1/13 (7.69%) 
General disorders   
Fatigue * 1  8/13 (61.54%) 
fever * 1  1/13 (7.69%) 
Hepatobiliary disorders   
Elevated liver function tests * 1  5/13 (38.46%) 
Metabolism and nutrition disorders   
Weight gain * 1  4/13 (30.77%) 
weight loss * 1  2/13 (15.38%) 
Musculoskeletal and connective tissue disorders   
spasm * 1  1/13 (7.69%) 
Nervous system disorders   
Somnolence * 1  9/13 (69.23%) 
Dizziness * 1  3/13 (23.08%) 
headache * 1  2/13 (15.38%) 
weakness * 1  1/13 (7.69%) 
Skin and subcutaneous tissue disorders   
allergic reaction * 1  1/13 (7.69%) 
1
Term from vocabulary, CTCAE (Unspecified)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Maureen Anne Leehey
Organization: University of Colorado
Phone: 303-724-2194
EMail: maureen.leehey@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02818777     History of Changes
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