Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062668) titled 'Effectiveness of Brivaracetam Used as the First Anti-Seizure Medication in Routine Clinical Practice for Japanese Patients with Epilepsy' on Aug. 25.

Study Type: Observational

Primary Sponsor: Institute - UCB Biopharma SRL

Condition: Condition - Epilepsy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effectiveness of brivaracetam initial monotherapy in adult patients with focal onset (partial onset) seizures after brivaracetam treatment initiation for at least 12 months. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.The patient has never received treatment with any antiseizure medication for any indication. The short acute use of rescue medication for seizure treatment is allowed. Any prior treatment with brivaracetam before brivaracetam initiation at study entry is not allowed. 2.The patient is 18 years of age or older at the timing of signing the Patient Data Consent Form (PDCF). 3.The patient has a confirmed clinical history of focal onset seizures and has had at least 1 focal onset seizures (focal aware, focal with impaired awareness, or focal to bilateral tonic-clonic seizures) during the past 6 months prior to baseline. 4.A PDCF is signed and dated by the patient. 5.The patient is considered by the treating physician to be reliable and capable of adhering to the protocol and is willing to be followed for a 24-month period. 6.The decision by the treating physician to prescribe brivaracetam tablets as initial monotherapy must be made independent from participation in the non-interventional study and is in line with the drug's license and the (local) summary of product characteristics. Key exclusion criteria - NA Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 30 Day Date of IRB - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2029 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071633

Disclaimer: Curated by HT Syndication.