Cannabis Extract in Refractory Epilepsy Study

Summary

The purpose of this study is to examine whether a low dose of CBD+THC will decrease the frequency of convulsive seizures in adults with drug-resistant epilepsy, when used in addition to standard anti-epileptic drugs (AEDs). This study will also study the genes associated with epilepsy and whether different epileptic syndromes respond to treatment with CBD+THC.

Conditions

• Drug Resistant Epilepsy

Interventions

DRUG

Medical Cannabis

The experimental intervention will begin with two weeks of titration (100 mg to 200 mg of CBD per day), followed by four weeks of treatment (maximum 300 mg of CBD per day) and four weeks of maintenance (maximum 300 mg of CBD per day). A two week washout phase will slowly decrease the daily dose (200 mg to 100 mg of CBD per day). All daily doses are equally divided into a morning and evening dose.

DRUG

Placebo

The placebo intervention will begin with two weeks of titration, followed by four weeks of treatment. Participants will then be unblinded to their study group and begin two weeks of titration, four weeks of treatment, and two weeks of washout with medical cannabis, following the same dosing and schedule as the experimental group. All daily doses are equally divided into a morning and evening dose.

Sponsors & Collaborators

• Ontario Brain Institute

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• MedReleaf

  collaborator INDUSTRY

• The Epilepsy Research Program of the Ontario Brain Institute

  lead OTHER

Principal Investigators

• W M Burnham, PhD · University of Toronto

• Peter Tai, MD · University Health Network, Toronto

• Seyed Mirsattari, MD · London Health Sciences Centre

• Nancy Mingo, MD · University Health Network, Toronto

• Danielle Andrade, MD · University Health Network, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-10

Primary Completion

2020-03-15

Completion

2020-03-15

Countries

• Canada

Study Locations