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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|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: cannabidiol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
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.
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.
Other Name: GWP42003-P
- Severity of Participants Reporting Study-related Adverse Events at Each Dose Level [ Time Frame: 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).
- Number of Participants Had Changes in Orthostatic Blood Pressure [ Time Frame: Baseline and 5 weeks ]Orthostatic blood pressure will be monitored at each study visit.
- Number of Participants Had Changes in Physical Exam [ Time Frame: Baseline and 5 weeks ]A physical exam will be performed at each study visit.
- Number of Participants Had Changes in EKG [ Time Frame: Baseline and 5 weeks ]EKG will be performed at each study visit.
- Number of Participants Had Changes in Laboratory Values [ Time Frame: Baseline and 5 weeks ]Laboratory tests (hematology, serum chemistry, and urinalysis) will be evaluated at each study visit.
- Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance [ Time Frame: Baseline and 5 weeks ]Assessing the proportion of subjects that drop out of the study due to study drug intolerance.
- Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score [ Time Frame: 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.
- Change in Montreal Cognitive Assessment (MoCA) [ Time Frame: 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.
- Change in Anxiety Short Form [ Time Frame: Baseline and 5 weeks ]This includes 8 items that assess severity of anxiety. Scores range 8-40. Higher values represent a worse outcome.
- Change in Neuropsychiatric Inventory (NPI) [ Time Frame: 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.
- Change in Depression Short Form [ Time Frame: Baseline and 5 weeks ]This includes 8 items that assess severity of depression. Score range 8-40. Higher values represent a worse outcome.
- Change in Scales for Outcomes in Parkinson's Disease (SCOPA)-Sleep-night Time Sleep [ Time Frame: Baseline and 5 weeks ]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.
- Change From Baseline of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) [ Time Frame: Baseline and 5 weeks ]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.
- Change in Emotional and Behavioral Dyscontrol Short Form [ Time Frame: Baseline and 5 weeks ]8 items that assess severity of emotional and behavioral dyscontrol. Scores range 8-40. Higher values represent a worse outcome.
- Change in Pain Severity Form [ Time Frame: Baseline and 5 weeks ]This will assess severity of pain. Scores range 3-15. Higher scores represent a worse outcome.
- Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) [ Time Frame: Baseline and 5 weeks ]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.
- Change in Fatigue Severity Scale [ Time Frame: Baseline and 5 weeks ]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.
- Change in International Restless Legs Syndrome Study Group Rating Scale for Restless [ Time Frame: Baseline and 5 weeks ]This encompasses a ten-question instrument for measuring severity of restless legs syndrome (RLS). Score range 0-40. Higher values represent a worse outcome.
- Change in Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: Baseline and 5 weeks ]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.
- Change in MDS-UPDRS Tremor Score (Total of Items 3.17 and 3.18) in the ON State [ Time Frame: Baseline and 5 weeks ]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.
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|Ages Eligible for Study:||40 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female subjects between 45 and 78 years of age inclusive.
- Willing and able to give informed consent.
- Idiopathic PD, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
- Rest tremor amplitude score of ≥2 in any limb on question 3.17 of the MDS-UPDRS (ON state).
- Anti-parkinsonian medication is fixed for at least 1 month prior to study entry
- If MoCA<22 subject must have a legally authorized representative (LAR) sign the consent, and must have a designated caregiver that agrees to ensure study protocols followed. This includes accompanying patient to study visits and being available for study phone calls.
- Must have a driver to drive them to and from study visits
- Has a significant other (someone who knows the subject well) that is appropriate for doing the NPI assessment, can accompany patient to study visits, and agrees to do so
- Agrees to not take more than 1 gram per day of acetaminophen, due to a possible interaction with study drug that could increase risk of hepatotoxicity.
- Known or suspected allergy to cannabinoids or excipients used in the study drug formulation.
- Cannabinoids taken currently or in the previous 30 days.
- History of drug or alcohol dependence; defined by prior inpatient stay(s) for this or that patient stats s/he has a history of this.
- Use of dopamine blockers within 180 days and amphetamine, cocaine, and MAO-A inhibitors within 90 days of baseline.
- Currently taking tolcapone, valproic acid, felbamate, niacin, isoniazid and ketoconazole due to risk of liver injury and clobazam and ketoconazole because of risk of toxic interactions with the study drug. These medications need to be stopped 90 days before the baseline visit.
- Unstable medical condition.
- Any of the following laboratory test results at screening:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818777
|United States, Colorado|
|University of Colorado School of Medicine|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Maureen A Leehey, M.D.||University of Colorado, Denver|
Documents provided by University of Colorado, Denver:
|Responsible Party:||University of Colorado, Denver|
|Other Study ID Numbers:||
|First Posted:||June 30, 2016 Key Record Dates|
|Results First Posted:||February 19, 2019|
|Last Update Posted:||February 19, 2019|
|Last Verified:||January 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
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