Health TrialsbyHealthPanel

CANnabinoids for Drug Resistant Epilepsy (DRE) in Adults and Children

ConditionDrug Resistant Epilepsy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age24-55
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    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 Isolate

    Drug

    CBD Isolate: MPL-015 is a CBD isolate, produced by MediPharm Labs, each mL contains 100mg CBD and 0mg THC.

  • CBD CHE

    Drug

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Arm 1 - Placebo Arm (MPL-012)Placebo comparator 1 intervention
Group B: Arm 2 - CBD Isolate (MPL-015)Experimental treatment 1 intervention
Group C: Arm 3 - CBD-CHE (MPL-016)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy in reducing seizure frequency

reported monthly seizure count from baseline to maintenance

Time frame
116 days
2

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

Time frame
116 + 60 days

Secondary outcomes

1

participant/family acceptability of this trial design

to be measured via post-study questionnaire, open-ended questions asked, no specific scale is used.

Time frame
116 days
2

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.

Time frame
116 days
3

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.

Time frame
176 days
4

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.

Time frame
116 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Research Manitoba

Collaborator

Source ClinicalTrials.gov

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