Cannabis Oil for Pain in Parkinson's Disease

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Full Title: A phase II, randomized, open-label, double-blind, two-center study to evaluate the tolerability, safety and dose-finding of oil cannabis preparation for pain in Parkinson's disease.

Short title: Cannabis oil for pain in Parkinson's disease Sample Size: N = 15 Study Population: Patients with Parkinson's disease and pain, without cognitive impairment.

Study Duration: July 2018 - July 2019

Study Agent/ Intervention: Cannabis oil: mixed oil cannabis preparation consisting of 3 different formulations of ∆-9THC and cannabidiol - 18:0; 10:10; and 1:20 respectively. Cannabis oil will be administered orally once per day, as required for pain; or taken 4h before bedtime, if no pain.

Primary objective: to determine the safety and tolerability of different formulations of Cannabis oil for pain in PD patients (incidence and severity of adverse events).

Secondary objective: to assess change from the start of treatment (V2) to end of treatment (V5) in frequency and severity of pain, sleep, dystonia and motor symptoms in PD patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Parkinson Society Canada

Criteria

Inclusion Criteria:

• Male and female subjects;

• Aged >18y

• International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson Disease.

• Bothersome Pain - Defined as Severity score of 2 or more (Moderate pain of some distress to the patient); and Frequency score of 2 or more (at least 1 episode/week) in at least one pain domain according to King's Parkinson Disease Pain Scale (KPPS, see supplements);

• On stable PD medications in the month prior to enrollment.

• Drugs used to treat pain, including dopaminergic drugs, analgesics, non-steroidal anti-inflammatories and opiates will be allowed to be continued during the study period but doses must be unchanged.

• Women of childbearing age must be non-pregnant and using a reliable method of contraception and have a negative pregnancy test at screening. Acceptable methods of contraception include using oral injected or implanted methods of hormonal contraceptives for at least 3 months prior to randomization and the partner should also use a barrier method (e.g. condom) with spermicidal foam/gel/film/cream/suppository during this study. Additional pregnancy testing will be completed if necessary throughout the study duration.

• Subject agrees not to drive for the duration of the study.

Exclusion Criteria:

• Secondary parkinsonism (as per MDS Diagnostic Criteria).

• Previous serious adverse event or hypersensitivity to cannabis or cannabinoids

• Current use of cannabinoids or marijuana within 90 days prior to screening.

• Cognitive impairment or dementia (Montreal Cognitive Assessment/MoCA < 24).

• Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorder Fifth Edition (DSM-5) and lifetime history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM-5

• History of clinically significant impulse control disorders: QUIP-RS- part A-D ≥ 10 and part E ≥ 7.

• Current suicidal ideation within one year prior to the second Screening Visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C-SSRS or attempted suicide within the last 5 years.

• Symptomatic orthostatic hypotension or drop in (standing from sitting) blood pressure of >20 mmHg (systolic) and >10 mmHg (diastolic).

• Significant hepatic disease (AST, ALT, ALP >2xUpper Normal Limit).

• Normal renal function (defined as serum creatinine level <133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60)

• Uncontrolled and severe cardiovascular disease, as per clinical judgment.

• History of problematic substance abuse, or substance use disorder, whether of alcohol, prescription drugs or illicit drugs

• Other contra-indication as per Health Canada recommendation for use of cannabis - see reference 21.

• Inability or unwillingness of subject to give written informed consent.

• Participation in another investigational study at the time of recruitment or during the prior month.

• Clinical use of any exclusionary drugs listed in Appendix I of this protocol