Condition or disease | Intervention/treatment | Phase |
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Drug Resistant Epilepsy | Drug: Medical Cannabis Drug: Placebo | Phase 3 |
Background: Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) are the two major compounds found in the cannabis plant. Reports from patients, families, and the scientific community suggest that CBD (when used as an add-on therapy) decreases the number of convulsive seizures in children and adults with Dravet syndrome, Lennox-Gastaut syndrome, and Tuberous sclerosis complex.
Trial design: Phase III, double-blind, randomized, placebo-controlled, parallel-group trial, followed by an open phase where treatment allocation will be revealed and all participants will either continue or begin receiving the active study drug.
Participants: Adults (18 years of age and older) with drug-resistant epilepsy, including patients with Dravet and Lennox Gastaut syndromes, and patients with frequent convulsive seizures (e.g., tonic, tonic-clonic, atonic, drop attacks, and focal motor seizures).
Interventions: Capsules containing a ratio of 16 CBD: 1 THC oil at a maximum total daily dose of approximately 300 mg of CBD per day, divided into equal doses in the morning and evening.
Comparator: Placebo capsules containing high-oleic sunflower oil and no active or medicinal ingredients.
Outcomes: Frequency of seizures; side effects; blood levels of AEDs, CBD, THC, and liver enzymes; impact on cognition and quality of life; genetics.
Sample size: A total of 80 participants (40 assigned to treatment and 40 to control group) recruited from Toronto Western Hospital in Toronto, and University Hospital in London, Ontario.
Time: Each participant will be enrolled for approximately 16 to 18 weeks, while the clinical trial is expected to take place over a period of two years.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Placebo-Controlled, Parallel-Group Study of Cannabidiol Plus Tetrahydrocannabinol (CBD+THC) Given as Adjunctive Therapy in Patients With Refractory Seizures |
Actual Study Start Date : | January 10, 2019 |
Actual Primary Completion Date : | March 15, 2020 |
Actual Study Completion Date : | March 15, 2020 |
Arm | Intervention/treatment |
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Experimental: Medical cannabis
Capsules containing cannabis extract, dissolved in high-oleic sunflower oil, and CBD/THC in a 16:1 ratio.
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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.
Other Name: CBD/THC
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Placebo Comparator: Placebo Control
Capsules containing a high-oleic sunflower oil, calorie-equated to the active treatment. There will be no active compounds in the placebo treatment. Following treatment with placebo, all participants in this group will begin treatment with medical cannabis. |
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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
University Hospital Campus, London Health Sciences Centre | |
London, Ontario, Canada | |
University Health Network - Toronto Western Hospital | |
Toronto, Ontario, Canada |
Principal Investigator: | W M Burnham, PhD | University of Toronto | |
Principal Investigator: | Peter Tai, MD | University Health Network, Toronto | |
Principal Investigator: | Seyed Mirsattari, MD | London Health Sciences Centre | |
Principal Investigator: | Nancy Mingo, MD | University Health Network, Toronto | |
Principal Investigator: | Danielle Andrade, MD | University Health Network, Toronto |
Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | January 11, 2019 | |||||||||||||||
First Posted Date ICMJE | January 18, 2019 | |||||||||||||||
Last Update Posted Date | September 11, 2020 | |||||||||||||||
Actual Study Start Date ICMJE | January 10, 2019 | |||||||||||||||
Actual Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures ICMJE |
Frequency of convulsive seizures [ Time Frame: 0 - 10 weeks ] | |||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Cannabis Extract in Refractory Epilepsy Study | |||||||||||||||
Official Title ICMJE | A Double-Blind, Placebo-Controlled, Parallel-Group Study of Cannabidiol Plus Tetrahydrocannabinol (CBD+THC) Given as Adjunctive Therapy in Patients With Refractory Seizures | |||||||||||||||
Brief 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. | |||||||||||||||
Detailed Description |
Background: Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) are the two major compounds found in the cannabis plant. Reports from patients, families, and the scientific community suggest that CBD (when used as an add-on therapy) decreases the number of convulsive seizures in children and adults with Dravet syndrome, Lennox-Gastaut syndrome, and Tuberous sclerosis complex. Trial design: Phase III, double-blind, randomized, placebo-controlled, parallel-group trial, followed by an open phase where treatment allocation will be revealed and all participants will either continue or begin receiving the active study drug. Participants: Adults (18 years of age and older) with drug-resistant epilepsy, including patients with Dravet and Lennox Gastaut syndromes, and patients with frequent convulsive seizures (e.g., tonic, tonic-clonic, atonic, drop attacks, and focal motor seizures). Interventions: Capsules containing a ratio of 16 CBD: 1 THC oil at a maximum total daily dose of approximately 300 mg of CBD per day, divided into equal doses in the morning and evening. Comparator: Placebo capsules containing high-oleic sunflower oil and no active or medicinal ingredients. Outcomes: Frequency of seizures; side effects; blood levels of AEDs, CBD, THC, and liver enzymes; impact on cognition and quality of life; genetics. Sample size: A total of 80 participants (40 assigned to treatment and 40 to control group) recruited from Toronto Western Hospital in Toronto, and University Hospital in London, Ontario. Time: Each participant will be enrolled for approximately 16 to 18 weeks, while the clinical trial is expected to take place over a period of two years. |
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Drug Resistant Epilepsy | |||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Terminated | |||||||||||||||
Actual Enrollment ICMJE |
17 | |||||||||||||||
Original Estimated Enrollment ICMJE |
80 | |||||||||||||||
Actual Study Completion Date ICMJE | March 15, 2020 | |||||||||||||||
Actual Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | Canada | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT03808935 | |||||||||||||||
Other Study ID Numbers ICMJE | EPL29 | |||||||||||||||
Has Data Monitoring Committee | No | |||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Responsible Party | The Epilepsy Research Program of the Ontario Brain Institute | |||||||||||||||
Study Sponsor ICMJE | The Epilepsy Research Program of the Ontario Brain Institute | |||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | The Epilepsy Research Program of the Ontario Brain Institute | |||||||||||||||
Verification Date | September 2020 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |