Status:
TERMINATED
Cannabis Extract in Refractory Epilepsy Study
Lead Sponsor:
The Epilepsy Research Program of the Ontario Brain Institute
Collaborating Sponsors:
Ontario Brain Institute
University of Toronto
Conditions:
Drug Resistant Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-...
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 ...
Eligibility Criteria
Inclusion
- Diagnosis of epilepsy according to the ILAE classification.
- At least 4 motor seizures per month at the start of the study, despite treatment with at least two different anti-epileptic drugs (given concurrently or sequentially) for at least one year.
- At least 4 motor seizures per month during the prospective baseline phase (4 weeks) with no 21-day seizure free periods.
- Stable dose(s) of the same AED(s) for one month prior to screening.
- Agrees not to take any cannabinoids during the study or any other investigational compound for one month before the study or outside cannabinoids during the study.
- Is planning to stay in Canada for the duration of the trial.
- Is able to travel to one of the study sites for in-person visits with the study physicians and to a local lab for blood collection.
- Has access to telephone, computer, and internet for regular correspondence and to complete the study questionnaires.
Exclusion
- Participation in a study involving administration of an investigational compound within one month of Visit 1.
- Evidence of clinically significant non-epileptic disease (cardiac, respiratory, gastrointestinal, hepatic, hematologic, or renal disease, etc.) that in the opinion of the investigators could affect the patient's safety or trial conduct.
- Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- Occurrence of psychogenic seizures in the previous year.
- History of drug misuse/abuse (other than cannabinoids). Consideration may be given to allowing inclusion of subjects with remote history of drug abuse (within a defined relevant time period).
- Multiple drug allergies (dermatological, hematological, or organ toxicity) or more than one severe drug reaction(s).
- Pregnancy, breastfeeding.
- Known or suspected hypersensitivity to cannabinoids, or any of the excipients of the investigational medicinal product.
- Patients with a history of major depression, suicidal ideation or attempted suicide, schizophrenia or any other psychotic disorder, patients with a family history of schizophrenia.
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03808935
Start Date
January 10 2019
End Date
March 15 2020
Last Update
September 11 2020
Active Locations (2)
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1
University Hospital Campus, London Health Sciences Centre
London, Ontario, Canada
2
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada