Phase 2
N=13
A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02818777 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Severity of Participants Reporting Study-related Adverse Events at Each Dose Level — 1; 1; 1; 1.25 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cannabidiol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Participants Reporting Study-related Adverse Events at Each Dose Level |
1; 1; 1; 1.25; 1.143; 1.25 | — |
| PRIMARY Number of Participants Had Changes in Orthostatic Blood Pressure |
— | — |
| PRIMARY Number of Participants Had Changes in Physical Exam |
— | — |
| PRIMARY Number of Participants Had Changes in EKG |
— | — |
| PRIMARY Number of Participants Had Changes in Laboratory Values |
5 | — |
| PRIMARY Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance |
3 | — |
| PRIMARY Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score |
-7.70 | — |
| PRIMARY Change in Montreal Cognitive Assessment (MoCA) |
1.0 | — |
| PRIMARY Change in Anxiety Short Form |
0.33 | — |
| PRIMARY Change in Neuropsychiatric Inventory (NPI) |
-0.125 | — |
| PRIMARY Change in Depression Short Form |
-0.85 | — |
| PRIMARY Change in Scales for Outcomes in Parkinson's Disease (SCOPA)-Sleep-night Time Sleep |
-2.80 | — |
| PRIMARY Change From Baseline of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) |
-0.7 | — |
| PRIMARY Change in Emotional and Behavioral Dyscontrol Short Form |
-4.69 | — |
| PRIMARY Change in Pain Severity Form |
-1.86 | — |
| PRIMARY Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) |
— | — |
| PRIMARY Change in Fatigue Severity Scale |
-0.5 | — |
| PRIMARY Change in International Restless Legs Syndrome Study Group Rating Scale for Restless |
-1.2 | — |
| PRIMARY Change in Unified Dyskinesia Rating Scale (UDysRS) |
1.0 | — |
| SECONDARY Change in MDS-UPDRS Tremor Score (Total of Items 3.17 and 3.18) in the ON State |
-0.4 | — |
Summary
The major purpose of the Stage 1 is to study the safety and tolerability of the proposed dosage regimen of the study drug. The form of cannabidiol (CBD) used in this study is GWP42003, supplied by GW Pharmaceuticals. The dosage regime is based on their experience. This is an open label study in 10 subjects, during which the dose is gradually increased to the manufacturers recommended target dose, with tolerability being evaluated at each dose level. Based on the response of subjects in the Stage 1, a target dose is determined for the next stage. Standardized tools will be administered to study both tolerability and efficacy. Efficacy assessments are simply explorative, and are done to look for an effect that warrants specific or different evaluation in the next stage.
Eligibility 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:
Data sourced from ClinicalTrials.gov (NCT02818777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.