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Cannabinoid

Cannabis Oil for Dementia (MDC-CAN-PD Trial)

Phase 2

Waitlist Available

Led By Susan Fox, MD, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (visit 1) to follow-up phone call (1 week after visit 5); total 35 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether cannabis oil is a safe and tolerable treatment for pain in Parkinson's disease patients. The study will also assess whether the oil affects pain, sleep, dystonia (a movement disorder), and motor symptoms.

Eligible Conditions

Dementia
Parkinson's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (visit 1) to follow-up phone call (1 week after visit 5); total 35 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (visit 1) to follow-up phone call (1 week after visit 5); total 35 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (visit 1) to follow-up phone call (1 week after visit 5); total 35 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) in each individual

Treatment-emergent adverse events (safety)

Secondary study objectives

Collect the King's Parkinson Disease Pain scale (KPPS) scores in the intervention group, adjusted for baseline scores.

Other study objectives

Changes in The Epworth Sleepiness Scale (ESS) (adjusted for baseline)

Changes in the Clinical global Impression of pain severity and improvement

Changes in the MDS-UPDRS part III (adjusted for baseline scores)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: CanniMed® Oil 1:20 formulationExperimental Treatment1 Intervention

∆9-THC: 1.0 mg/mL; CBD: 20.0 mg/mL

Group II: CanniMed® Oil 18:0 formulationExperimental Treatment1 Intervention

∆9-THC: 18.3 mg/mL; CBD: 0.2 mg/mL

Group III: CanniMed® Oil 10:10 formulationExperimental Treatment1 Intervention

∆9-THC: 9.8 mg/mL; CBD: 9.9 mg/mL

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Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,520 Previous Clinical Trials

503,229 Total Patients Enrolled

17 Trials studying Dementia

2,048 Patients Enrolled for Dementia

Parkinson Society CanadaOTHER

3 Previous Clinical Trials

140 Total Patients Enrolled

Susan Fox, MD, PhDPrincipal InvestigatorUHN - Toronto Western Hospital - 399 Bathurst Street, McLaughlin pavilion, 7th Floor Toronto, ON, M5T 2S8 - Canada