protocolSection identificationModule nctId: NCT06374966, orgStudyIdInfo id: 2024-0246, briefTitle: Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, collaborators name: Hangzhou Children's Hospital, collaborators name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, collaborators name: Jinhua Second Hospital, collaborators name: Ningbo Medical Center Lihuili Hospital, collaborators name: Ningbo Women & Children's Hospital, collaborators name: Yuyao People's Hospital, collaborators name: Huzhou Third People's Hospital, collaborators name: The Second Affiliated Hospital of Jiaxing University, collaborators name: Lishui Country People's Hospital, descriptionModule briefSummary: Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition., conditionsModule conditions: Epilepsies, Partial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Zonisamide, outcomesModule primaryOutcomes measure: Effective rate at 6 months of treatment, secondaryOutcomes measure: Effective rate at 3 months of treatment, secondaryOutcomes measure: Total time to treatment failure, secondaryOutcomes measure: Incidence of side effects, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hangzhou Children's Hospital, city: Hangzhou, state: Zhejiang, zip: 310005, country: China, contacts name: Zhanli Liu, doctorate, role: CONTACT, phone: 15968194368, email: liuzhanli@126.com, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, contacts name: Shuang Wang, doctorate, role: CONTACT, phone: 13588817561, email: wangs77@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Huzhou Third People's Hospital, city: Huzhou, state: Zhejiang, zip: 313002, country: China, contacts name: Changguo Zhang, doctorate, role: CONTACT, phone: 15957288075, email: zhangcg1981@163.com, geoPoint lat: 30.8703, lon: 120.0933, locations facility: Jiaxing Second hospital, city: Jiaxing, state: Zhejiang, zip: 314099, country: China, contacts name: Xiaoxiang Yu, doctorate, role: CONTACT, phone: 13567340650, email: 43262048@qq.com, geoPoint lat: 30.7522, lon: 120.75, locations facility: Jinhua Second hospital, city: Jinhua, state: Zhejiang, zip: 321016, country: China, contacts name: Suhong Ye, doctorate, role: CONTACT, phone: 13757990511, email: 1073774376@qq.com, geoPoint lat: 29.10678, lon: 119.64421, locations facility: The Fourth Affilicated Hospital of Zhejiang University School of Medicine, city: Jinhua, state: Zhejiang, zip: 322099, country: China, contacts name: Jiajia Fang, doctorate, role: CONTACT, phone: 15215880868, email: fangjjiaj@zju.edu.cn, geoPoint lat: 29.10678, lon: 119.64421, locations facility: Lishui People's Hospital, city: Lishui, state: Zhejiang, zip: 323050, country: China, contacts name: Likang Lan, doctorate, role: CONTACT, phone: 18957090351, email: lsllk67@163.com, geoPoint lat: 28.46042, lon: 119.91029, locations facility: Ningbo Women And Children's Hospital, city: Ningbo, state: Zhejiang, zip: 315012, country: China, contacts name: Minghai Huang, doctorate, role: CONTACT, phone: 13605742462, email: hmhai432@126.com, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Ningbo Medical center Lihuili hospital, city: Ningbo, state: Zhejiang, zip: 315048, country: China, contacts name: Xiaoqin Fan, doctorate, role: CONTACT, phone: 13685739576, email: fanteacher@163.com, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Yuyao People's hospital, city: Yuyao, state: Zhejiang, zip: 315499, country: China, geoPoint lat: 30.05, lon: 121.14944, hasResults: False