Drug Resistant EpilepsyPhase 2CAN-DRENCT07023744
CANnabinoids for Drug Resistant Epilepsy (DRE) in Adults and Children
A Phase 2 study testing CBD Isolate and CBD CHE in people with Drug Resistant Epilepsy, run by University of Manitoba.
Trial summary
Epilepsy is a neurological disorder affecting more than 50 million people globally, including more than 260,000 Canadians. Cannabidiol (CBD) reduces seizure frequency and improves quality of life for adults and children with Drug Resistant Epilepsy (DRE). Read more about this study
- Who is it for?
- Ages 24 months to 55 years
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- CBD Isolate and CBD CHE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 27 Jul 2026to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 24 months to 55 years old at the time of enrollment
- Diagnosed with DRE: not achieved seizure freedom, with adequate trials of 2 antiseizure medications 29
- Medical history of 4 + clinically recognizable seizures (any type with clusters counted as a single event) per month
- Have a negative pregnancy test at screening for patients who have experienced menarche
- Agree to abstain from driving and recreational cannabis use throughout the study
Who cannot join
- Diagnosis of psychogenic non-epileptic seizure
- Recent (<30 days) change in anticonvulsant therapies including anticonvulsant medications, or settings on vagal nerve stimulator
- Ketogenic diet started within 6 months (participants stable on the ketogenic diet for more than 6 months are eligible to participate)
- Vagal nerve stimulator implanted and activated within 12 months
- Concomitant regular use of narcotics (except in emergencies and physician supervised)
- Initiation or dosage change of oral or injected steroids within 3 months
Show all 13Show fewer
- Allergy or intolerance to compounds in trial preparations
- DRE secondary to progressive neurological disease
- Clinically significant cardiac, renal or hepatic disease (as assessed by site investigator); elevated liver enzymes (GGT and/or AST and/or ALT) or lipase >3 times upper limit, adjusted for age
- History of psychotic disorders
- Uncontrolled (in the perspective of the qualified investigator) medical conditions including substance use disorders
- History or concurrent cannabis use disorder
- Unwilling or unable to use highly effective methods of contraception throughout the study period and three months post-trial, where applicable
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Triple-Blind, Placebo-Controlled, Randomized Clinical Trial of CANnabinoids for Drug Resistant Epilepsy in Adults and Children
Epilepsy is a neurological disorder affecting more than 50 million people globally, including more than 260,000 Canadians. Cannabidiol (CBD) reduces seizure frequency and improves quality of life for adults and children with Drug Resistant Epilepsy (DRE). Several uncontrolled, small, open label studies reported that CBD-enriched Cannabis Herbal Extract (CHE) resulted in a reduction of seizure frequency, but we lack critical information on efficacy, comparative effectiveness and dosing of CBD and ∆9-tetrahydrocannabinol (THC) in children and adults with DRE. CAN-DRE is an early phase, triple-blind, placebo-controlled, randomized clinical trial to answer the questions of if cannabinoids work to reduce seizures in children and adults (24 months to 55 years) with DRE and if CBD works better in an isolate or in a CBD-enriched Cannabis Herbal Extract. The primary outcome of CAN-DRE is reported monthly seizure count from baseline to maintenance phase.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- Placebo, CBD Isolate, CBD CHE
- Keywords
- adult and children, cannabis, DRE, CBD-isolate, CBD-enriched Cannabis Herbal Extract (CHE), cannabidiol
- Medical subject headings
- Drug Resistant Epilepsy, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo arm: participants will receive Placebo MPL-012 oil only through the trial participation. MPL-012 is produced by MediPharm Labs, each mL contains 0mg CBD and 0mg THC.
CBD IsolateDrug
CBD Isolate: MPL-015 is a CBD isolate, produced by MediPharm Labs, each mL contains 100mg CBD and 0mg THC.
CBD CHEDrug
CBD-CHE arm: MPL -016 is a CBD-enriched cannabis herbal extract, produced by MediPharm Labs, each mL contains 100mg of CBD and 3mg of THC.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Placebo Arm (MPL-012) | Placebo comparator | Placebo arm -> MPL-012 oil, each mL contains 0mg CBD and 0mg THC. Receives: Drug: Placebo |
| Arm 2 - CBD Isolate (MPL-015) | Experimental | CBD-Isolate arm -> MPL-015 oil, each ml contains 100mg CBD and 0mg THC. Receives: Drug: CBD Isolate |
| Arm 3 - CBD-CHE (MPL-016) | Experimental | CBD-CHE arm -> MPL-016 oil, a CBD-enriched cannabis herbal extract, each ml contains 100mg CBD and 3mg THC. Receives: Drug: CBD CHE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in reducing seizure frequency
reported monthly seizure count from baseline to maintenance
Measured: 116 days
Cannabinoid-related AEs and DLTs
The frequency and type of adverse events and dose limiting toxicities (DLTs) reported by caregivers and participants throughout the trial participation
Measured: 116 + 60 days
Secondary outcomes (5)
participant/family acceptability of this trial design
to be measured via post-study questionnaire, open-ended questions asked, no specific scale is used.
Measured: 116 days
Quality of Life reported by adult participant/family
Quality of Life in Epilepsy Inventory (QOLIE-31) tool for adult participants. Changes from baseline to maintenance phase will be compared to measure the outcome.
Measured: 116 days
health resource utilization and changes
A trial-specific Health Resource Utilization Questionnaire (HRUQ) is used to collect epilepsy participants' healthcare resource usage and out-of-pocket healthcare expenses during trial participation. The data will be analyzed descriptively to measure direct and indirect healthcare resource utilization related to the intervention from baseline phase to 60-day follow up post study protocolized treatment.
Measured: 176 days
changes in work and activity impairment affected by seizure
WPAI (Work Productivity and Activity Impairment Questionnaire) asks about the effect of participant's seizure on their/their caregivers' ability to work and perform regular activities. Changes reported from baseline to maintenance phase will be compared.
Measured: 116 days
Quality of Life reported by pediatric participants and family
Quality of Life in Childhood Epilepsy (QOLCE-55) tool for pediatric participants (4 - 17 yrs). Changes from baseline to maintenance phase will be compared to measure the outcome.
Measured: 116 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start27 Jul 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- an early phase, triple-blind, placebo-controlled, randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Research Manitoba
- Responsible party
- Principal investigator, Lauren Kelly, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023744
- Sponsor's protocol ID
- CAN-DRE
- Acronym
- CAN-DRE
- Status last verified
- Jun 2026
- First submitted
- 22 May 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No, summary level data may be available from the CAN-DRE steering committee following research ethics board approval.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple-Blind, Placebo-Controlled, Randomized Clinical Trial of CANnabinoids for Drug Resistant Epilepsy in Adults and Children
- ClinicalTrials.gov ID
- NCT07023744
- Acronym / sponsor ID
- CAN-DRE / CAN-DRE
- Conditions
- Drug Resistant Epilepsy
- Keywords
- adult and children, cannabis, DRE, CBD-isolate, CBD-enriched Cannabis Herbal Extract (CHE), cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Research Manitoba
- Study start
- 27 Jul 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epilepsy is a neurological disorder affecting more than 50 million people globally, including more than 260,000 Canadians. Cannabidiol (CBD) reduces seizure frequency and improves quality of life for adults and children with Drug Resistant Epilepsy (DRE). Several uncontrolled, small, open label studies reported that CBD-enriched Cannabis Herbal Extract (CHE) resulted in a reduction of seizure frequency, but we lack critical information on efficacy, comparative effectiveness and dosing of CBD and ∆9-tetrahydrocannabinol (THC) in children and adults with DRE. CAN-DRE is an early phase, triple-blind, placebo-controlled, randomized clinical trial to answer the questions of if cannabinoids work to reduce seizures in children and adults (24 months to 55 years) with DRE and if CBD works better in an isolate or in a CBD-enriched Cannabis Herbal Extract. The primary outcome of CAN-DRE is reported monthly seizure count from baseline to maintenance phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- an early phase, triple-blind, placebo-controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Placebo Arm (MPL-012) | Placebo comparator | Drug: PlaceboPlacebo arm -> MPL-012 oil, each mL contains 0mg CBD and 0mg THC. |
| Arm 2 - CBD Isolate (MPL-015) | Experimental | Drug: CBD IsolateCBD-Isolate arm -> MPL-015 oil, each ml contains 100mg CBD and 0mg THC. |
| Arm 3 - CBD-CHE (MPL-016) | Experimental | Drug: CBD CHECBD-CHE arm -> MPL-016 oil, a CBD-enriched cannabis herbal extract, each ml contains 100mg CBD and 3mg THC. |
Who may qualify
- Ages
- 24 months to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 24 months to 55 years old at the time of enrollment
- Diagnosed with DRE: not achieved seizure freedom, with adequate trials of 2 antiseizure medications 29
- Medical history of 4 + clinically recognizable seizures (any type with clusters counted as a single event) per month
- Have a negative pregnancy test at screening for patients who have experienced menarche
- Agree to abstain from driving and recreational cannabis use throughout the study
Key exclusion criteria (13 listed)
- Diagnosis of psychogenic non-epileptic seizure
- Recent (<30 days) change in anticonvulsant therapies including anticonvulsant medications, or settings on vagal nerve stimulator
- Ketogenic diet started within 6 months (participants stable on the ketogenic diet for more than 6 months are eligible to participate)
- Vagal nerve stimulator implanted and activated within 12 months
- Concomitant regular use of narcotics (except in emergencies and physician supervised)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo arm: participants will receive Placebo MPL-012 oil only through the trial participation. MPL-012 is produced by MediPharm Labs, each mL contains 0mg CBD and 0mg THC. | Drug | Arm 1 - Placebo Arm (MPL-012) |
| CBD IsolateCBD Isolate: MPL-015 is a CBD isolate, produced by MediPharm Labs, each mL contains 100mg CBD and 0mg THC. | Drug | Arm 2 - CBD Isolate (MPL-015) |
| CBD CHECBD-CHE arm: MPL -016 is a CBD-enriched cannabis herbal extract, produced by MediPharm Labs, each mL contains 100mg of CBD and 3mg of THC. | Drug | Arm 3 - CBD-CHE (MPL-016) |
Primary outcome
Efficacy in reducing seizure frequency
Time frame: 116 days
reported monthly seizure count from baseline to maintenance
Cannabinoid-related AEs and DLTs
Time frame: 116 + 60 days
The frequency and type of adverse events and dose limiting toxicities (DLTs) reported by caregivers and participants throughout the trial participation
5 secondary outcomes
participant/family acceptability of this trial design
Time frame: 116 days
Quality of Life reported by adult participant/family
Time frame: 116 days
health resource utilization and changes
Time frame: 176 days
changes in work and activity impairment affected by seizure
Time frame: 116 days
Quality of Life reported by pediatric participants and family
Time frame: 116 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided. No, summary level data may be available from the CAN-DRE steering committee following research ethics board approval.
Related trials for Drug Resistant Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingPhase 1
A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Recruiting
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBD Isolate and CBD CHE in people with Drug Resistant Epilepsy, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Kelly, PhD (204-242-3179, lauren.kelly@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in reducing seizure frequency (time frame: 116 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.