I-CANN Japan trial

JRCT ID: jRCTs031240495

Registered date:19/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Drug Resistant Epilepsy
• Date of first enrollment: 19/11/2024
• Target sample size: 150
• Study type: Interventional
• Intervention(s): cannabinoids

Outcome(s)

• Primary Outcome: Seizure frequency
• Secondary Outcome: adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1Patients whose epileptic seizures remain uncontrolled for two years 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

Exclude 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

Related Information

• Primary Sponsor: Takumi Ichiro
• Source(s) of Monetary Support: MHLW Scientific research fund