Cannabis Extract in Refractory Epilepsy Study

• Status: Terminated
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Epilepsy Research Program of the Ontario Brain Institute
• Collaborators: London Health Sciences Centre; MedReleaf; Ontario Brain Institute; University Health Network, Toronto; University of Toronto

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.