Drug Resistant Epilepsy Epilepsy
Conditions
Interventions
D002186
Sponsors
Takumi Ichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1Patients whose epileptic seizures remain uncontrolled for one year despite monotherapy (or combination therapy) with two major antiepileptic drugs (Carbamazepine, phenytoin, phenobal, zonisamide, valproate, etc.) 2Patients who have been using cannabinoid products (foods) that are no longer available after the enforcement date of the Narcotics and Psychotropic Substances Control Act (December 12, 2024) who wish to use the study drug cannabinoid (Step 1) or who wish to use the study drug cannabinoid (Step 2) 3Patients who were judged to be eligible to participate in this clinical study through individual review by the Appropriate Cannabinoid Use Committee of the Japan Society of Clinical Cannabinoids 4Patients who were over one year old at the time of informed consent 5Patients who have obtained written consent from research subjects or legal guardians
Exclusion criteria
Exclusion criteria: 1)Patients with a history of serious hypersensitivity or anaphylactic reaction to cannabinoid-derived products 2)Patients who are currently participating in another clinical trial. or who have participated in a clinical trial and have not taken the study drug for more than 1 month 3)Patients who are or are likely to be pregnant 4)Patients who are unable to enroll in the study online or by electronic device, enter data, or transmit data via the Internet by the study participant or proxy 5)Patients who are judged by the principal investigator or subinvestigator to be unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event | — |
Contacts
Public ContactIchiro Takumi
St.Marianna University School of Medicine
Outcome results
None listed