Recruiting
Phase 2

Cannabis Oil

Sponsor:

University Health Network, Toronto

Code:

NCT03639064

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cannabis Oil

Study Details

Brief 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.

Conditions

Parkinson Disease

Study ID

NCT03639064

Start date

Dec 1, 2020

Status verified date

Nov, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CanniMed® Oil 1:20 formulation

∆9-THC: 1.0 mg/mL; CBD: 20.0 mg/mL

experimental: CanniMed® Oil 10:10 formulation

∆9-THC: 9.8 mg/mL; CBD: 9.9 mg/mL

experimental: CanniMed® Oil 18:0 formulation

∆9-THC: 18.3 mg/mL; CBD: 0.2 mg/mL

Interventions

Cannabis Oil

Mixed oil cannabis preparation consisting of 3 differing formulations of ∆-9THC and CBD is clinically available in Canada as CanniMed®. The 3 differing formulations of CanniMed® oils contain varying proportions of ∆-9THC and CBD in the following ratios: 18:0; 10:10; 1:20.

All CanniMed® oil formulations consist of cannabinoids extracted from dried cannabis, and diluted in olive oil.

Primary outcome measure

  • Maximum tolerated dose (MTD) in each individual [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days of intervention. ]
  • Treatment-emergent adverse events (safety) [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days of intervention. ]

Central Contacts and Locations

Central contacts

Susan Fox, MD, PhD

416-699-9837sfox@uhnresearch.ca

Carlos Ropa, Coordinator

416-603-5800Carlos.Ropa@uhnresearch.ca

Locations

Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St

Recruiting

Toronto, Ontario, Canada, M5V 2T8

Contacts

Carlos Ropa

Carlos.Ropa@uhnresearch.ca

Principal Investigator:

Susan H Fox, MRCP, PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 10, 2022

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2022-03-10.