A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Tremor
Intervention: cannabidiol
Intervention description: 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.
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Tremor; tolerability; safety; cognition; anxiety; psychosis; mood; dyskinesia; cannabidiol; cannabis; efficacy; sleep; motor symptoms; non-motor symptoms; quality of life; marijuana

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: