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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02818777
Date of registration: 06/05/2016
Prospective Registration: Yes
Primary sponsor: University of Colorado, Denver
Public title: A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease
Scientific title: A Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease
Date of first enrolment: July 2016
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02818777
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Maureen A Leehey, M.D.
Address: 
Telephone: 303-724-2194
Email: maureen.leehey@ucdenver.edu
Affiliation: 
Name:     Maureen A Leehey, M.D.
Address: 
Telephone: 1-303-724-2194
Email: maureen.leehey@ucdenver.edu
Affiliation: 
Name:     Maureen A Leehey, M.D.
Address: 
Telephone:
Email:
Affiliation:  University of Colorado, Denver
Key inclusion & exclusion criteria

Stage 1:

Inclusion criteria:

- 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.

Exclusion criteria:

- 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:



Age minimum: 45 Years
Age maximum: 78 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Drug: cannabidiol
Drug: placebo
Primary Outcome(s)
Change from baseline of REM sleep behavior disorder screening questionnaire (RBDSQ) [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Anxiety short form [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Cognitive Assessment Battery [Time Frame: Stage 2: Baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Depression short form [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in emotional and behavioral dyscontrol short form [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in EuroQoL-5 Dimension 5 level (EQ-5D-5L) [Time Frame: Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Fatigue severity scale [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in International Restless Legs Syndrome Study Group Rating Scale for restless [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in MDS-UPDRS total score [Time Frame: Stage 1: Baseline to day 22-27, baseline to day 36 +/-4. Stage 2: Baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4), baseline to day 129+/-4.]]
Change in Montreal Cognitive Assessment (MoCA) [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Neuropsychiatric Inventory (NPI) [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Pain severity and intensity short form [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Rapid Paced Walk test [Time Frame: Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Scales for Outcomes in Parkinson's disease (SCOPA)-sleep [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) [Time Frame: Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Change in Unified Dyskinesia Rating Scale (UDysRS) [Time Frame: Stage 1: Baseline to day 22-27. Stage 2: baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4).]
Changes in EKG [Time Frame: Stage 1: Baseline to end of treatment phase up to 3 weeks. Stage 2: Baseline to end of each treatment phase up to 7 weeks and 15 weeks for each treatment period.]
Changes in Laboratory Values [Time Frame: Stage 1: Baseline to end of treatment phase up to 3 weeks. Stage 2: Baseline to end of each treatment phase up to 7 weeks and 15 weeks for each treatment period.]
Changes in Physical Exam [Time Frame: Stage 1: Baseline to end of treatment phase up to 3 weeks. Stage 2: Baseline to end of each treatment phase up to 7 weeks and 15 weeks for each treatment period.]
Changes in Vital Signs [Time Frame: Stage 1: Baseline to end of treatment phase up to 3 weeks. Stage 2: Baseline to end of each treatment phase up to 7 weeks and 15 weeks for each treatment period.]
Frequency of study-related adverse events at each dose level [Time Frame: Stage 1: Every 3rd day on each dose level, assessed up to 5 weeks; Stage 2: Every 3rd day on each dose level, assessed up to 19 weeks.]
Proportion of subjects that drop out of the study due to study drug intolerance [Time Frame: Stage 1: Baseline to end of treatment phase up to 3 weeks. Stage 2: Baseline to end of each treatment phase up to 7 weeks and 15 weeks for each treatment period.]
Secondary Outcome(s)
Change in MDS-UPDRS tremor score (total of Items 3.17 and 3.18) in the ON state [Time Frame: Stage 1: Baseline to day 22-27, baseline to day 36 +/-4. Stage 2: Baseline to each low dose visit (day 10-15, 78-83), baseline to each end of treatment phase (day 47+/-4, 115+/-4), baseline to day 129+/-4.]]
Secondary ID(s)
15-0929
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Colorado Department of Public Health and Environment
GW Research Ltd
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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