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MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID)

MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.

MRCP001

Lisa Rudd-Scott

Erin McGean

Marissa Slaven, MD

This project represents a first systematic, prospective, single-arm cohort study of a safe and effective dosing regimen of an orally administered cannabis oil formulation in a cancer subject population with poorly controlled pain.

Over a 1-2 year period, 40 cancer patients experiencing poorly controlled pain will be enrolled in to a prospective single-arm cohort study, in which they will receive an orally administered cannabis oil formulation as an add-on therapy to current treatment regimens. Subjects entering the acute study phase will be titrated to a tolerated dose at which a sustained pain response is reached, and may subsequently enter a 12 week chronic phase during which safety and durability of pain response will be assessed at their stable dose.

Cannabis Oil for Pain Effectiveness

Two successive pain responses (Reduction in pain as measured by the Brief Pain Inventory - Short form (BPI-SF) with no increase MME or decrease in MME, continuing for 7 days after dose stabilization)

Reduction in pain as measured by the BPI-SF with no increase MME or decrease in MME

As measured by the Hospital Anxiety and Depression Scale (HADS) in which 14 questions are scored on a scale of 0-3. A cumulative score of ≥ 11 will result in a subject being classified as having anxiety and depression using the HADS anxiety and depression, respectively.

As measured by the Edmonton Symptom Assessment Scale (ESAS), which is routinely performed in most cancer centres in Ontario, and scores pain as well as other cancer-related symptoms between 0-10, 10 being worst possible.

As measured by the Functional Assessment of Cancer Therapy (FACT-G)

As measured by the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a scale which assigns scores between 0-5 to 7 pain-related outcomes, a cut off ≥ 12 classifying subjects as predominantly having neuropathic pain.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cannabis Oil for Pain Effectiveness	NCT03522467	Cancer Chronic Pain	MRCP001	25 Years - 70 Years	Aurora Cannabis Inc
Cannabis Oil for Pain Effectiveness	NCT03522467	Cancer Chronic Pain	MRCP001	25 Years - 70 Years	Aurora Cannabis Inc

Spots Global Cancer Trial Database for mrcp001

Every month we try and update this database with for mrcp001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mrcp001

Every month we try and update this database with for mrcp001 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mrcp001 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.