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Trial record 25 of 55 for:    Recruiting, Not yet recruiting, Available Studies | NOT (Use Disorders OR Marijuana Use OR Dependence OR Abuse OR Drug Use) | cannabinoids

Cannabis Oil for Pain in Parkinson's Disease (MDC-CAN-PD)

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ClinicalTrials.gov Identifier: NCT03639064
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
Parkinson Society Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Cannabis Oil Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is an interventional, phase II, randomized, open-label, double-blind, two-centre study to evaluate the safety, tolerability, and dose-finding of Cannabis oil preparation for pain in Parkinson's disease.

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. A total of 15 patients will be block randomized to one of the three groups. Each patient will receive one formulation of CanniMed® Oil only, with 5 patients per group.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This will be a double-blind study. The different cannabis oil formulations have the same colour, taste and smell. Study investigators will be blind to the dose/formulation of cannabis oil. Unblinding will only be performed in the event of a Serious AE. The site PI will maintain a randomization list kept in a locked secure 24h a day accessible location for emergency unblinding.
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CanniMed® Oil 1:20 formulation
∆9-THC: 1.0 mg/mL; CBD: 20.0 mg/mL
Drug: 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.


Experimental: CanniMed® Oil 10:10 formulation
∆9-THC: 9.8 mg/mL; CBD: 9.9 mg/mL
Drug: 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.


Experimental: CanniMed® Oil 18:0 formulation
∆9-THC: 18.3 mg/mL; CBD: 0.2 mg/mL
Drug: 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 Measures :
  1. Maximum tolerated dose (MTD) in each individual [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days of intervention. ]
    MTD will be defined as the dose of each CanniMed® preparation for which the subject was able to be on for a minimum of 1 week, without the occurrence of an AE or suspected AE, with the severity grading of 2 or higher (CTCAE v.4.0)

  2. Treatment-emergent adverse events (safety) [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days of intervention. ]
    Determine the incidence and severity of adverse events by direct patient questioning, physical examination and ancillary testing as per protocol


Secondary Outcome Measures :
  1. Collect the King's Parkinson Disease Pain scale (KPPS) scores in the intervention group, adjusted for baseline scores. [ Time Frame: From baseline (Visit 1) to Follow-up phone call (1 week after Visit 5); Total 35 days ]
    KPPS is a validated, disease-specific scale with seven domains (different types of pain) including 14 items, each item scored by severity (0-3) multiplied by frequency (0-4) with a total possible score range from 0 to 168.


Other Outcome Measures:
  1. Changes in the Visual Analogue Scale for Pain (adjusted for baseline scores) [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days. ]
    The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  2. Changes in the MDS-UPDRS part III (adjusted for baseline scores) [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days. ]
    The score assesses the motor signs of PD and ranges between 0-137.

  3. Changes in the UDysRS - Dystonia part 2 subscores (adjusted for baseline) [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days. ]
    The scale is divided in 2 parts. Part 2A is administered by the rater (one question) and focuses on time spent with off-dystonia. Part 2B is a component of the Patient Questionnaire that covers three questions on the impact of painful off-dystonia on experiences of daily living. The score ranges between 0-16.

  4. Changes in the Clinical global Impression of pain severity and improvement [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days. ]
    The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

  5. Changes in The Epworth Sleepiness Scale (ESS) (adjusted for baseline) [ Time Frame: From baseline (Visit 1) to end of study (Visit 5); total 35 days. ]
    The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639064


Contacts
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Contact: Susan Fox, MD, PhD 416-699-9837 sfox@uhnresearch.ca
Contact: Deborah Mancini, Coordinator 416-603-5800 ext 3684 deborah.mancini@uhnresearch.ca

Sponsors and Collaborators
University Health Network, Toronto
Parkinson Society Canada
Investigators
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Principal Investigator: Susan Fox, MD, PhD UHN - Toronto Western Hospital - 399 Bathurst Street, McLaughlin pavilion, 7th Floor Toronto, ON, M5T 2S8 - Canada

Additional Information:
Publications of Results:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03639064     History of Changes
Other Study ID Numbers: 17-6086.0
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases