Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063262) titled 'A Prospective Observational Study Evaluating Outcomes in Patients with Epilepsy Switched from Levetiracetam Monotherapy to Brivaracetam Monotherapy Due to Adverse Drug Reaction' on Oct. 15.

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 change from baseline at 12W in severity of adverse drug reactions to levetiracetam in patients who transitioned to brivaracetam monotherapy after discontinuation of levetiracetam monotherapy due to occurrence of adverse drug reactions Basic objectives2 - Safety

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.The patient is 18 years of age or older at the time of signing the Patient Data Consent Form (PDCF). 2.The patient has a confirmed clinical history of focal onset seizures with or without focal to bilateral tonic-clonic seizures. 3.The patient has never been treated with brivaracetam before. 4.The patient has been receiving levetiracetam monotherapy prior to baseline and must discontinue levetiracetam treatment due to intolerable adverse drug reactions. 5.A PDCF is signed and dated by the patient. 6.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 12 weeks period. 7.The decision by the treating physician to prescribe brivaracetam is made independent from participation in the non-interventional study and in line with the drug 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 05 Month 22 Day Date of IRB - 2026 Year 08 Month 31 Day Anticipated trial start date - 2026 Year 10 Month 22 Day Last follow-up date - 2028 Year 05 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072414

Disclaimer: Curated by HT Syndication.