NCT07023744Not yet recruitingPhase 2
CANnabinoids for Drug Resistant Epilepsy (DRE) in Adults and Children
A Triple-Blind, Placebo-Controlled, Randomized Clinical Trial of CANnabinoids for Drug Resistant Epilepsy in Adults and Children
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 22 May 2025
- Start date
- 27 Jul 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- University of Manitoba
- Diseases
- Epilepsy
- NCT number
- NCT07023744
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 27 Jul 2026 to the primary completion date, 31 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (\<30 days) change in anticonvulsant therapies including anticonvulsant medications, or settings on vagal nerve stimulator
- Concomitant regular use of narcotics (except in emergencies and physician supervised)
- Initiation or dosage change of oral or injected steroids within 3 months
- History or concurrent cannabis use disorder
Other illness
- Diagnosis of psychogenic non-epileptic seizure
- Allergy or intolerance to compounds in trial preparations
- DRE secondary to progressive neurological disease
- History of psychotic disorders
- Uncontrolled (in the perspective of the qualified investigator) medical conditions including substance use disorders
Lab values
- 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
Other
- 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
- Unwilling or unable to use highly effective methods of contraception throughout the study period and three months post-trial, where applicable
Who the study is looking for
- 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
Age in the registry: 24 months to 55 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.