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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.
1. Before starting zonisamide treatment, a 4-week baseline observation period is required, which needs to meet the following criteria: no medication adjustment and at least 2 times of seizure per 4 weeks. 2. If patients meet the criteria for the baseline period, after the baseline observation period, they are required to complete the blood routine, urine routine, renal function, liver function, ultrasound of the urinary tract, and scale completion (including the QOLIE-31 quality of life scale, GAD-7, C-NDDI-E, Pittsburgh sleep quality, and the Epworth Sleepiness Scale (ESS)) prior to initiating treatment. If the patient still meets the inclusion criteria, zonisamide may be added to the treatment, and the patient's seizures and medications prior to zonisamide treatment will be recorded. 3. Outpatient follow-up and scale filling were carried out in the 1st, 3rd and 6th month of zonisamide treatment, and blood tests were reviewed in the first/third (according to the clinical situation) and sixth month, and urological ultrasound was reviewed in the sixth month, and imaging and electrophysiological examinations were carried out according to the clinical need in the light of the actual situation of the patients, and the changes of seizures and side effects during the medication period were recorded in detail.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
Hangzhou Children's Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Huzhou Third People's Hospital
Huzhou, Zhejiang, China
Jiaxing Second hospital
Jiaxing, Zhejiang, China
Jinhua Second hospital
Jinhua, Zhejiang, China
The Fourth Affilicated Hospital of Zhejiang University School of Medicine
Jinhua, Zhejiang, China
Lishui People's Hospital
Lishui, Zhejiang, China
Ningbo Women And Children's Hospital
Ningbo, Zhejiang, China
Ningbo Medical center Lihuili hospital
Ningbo, Zhejiang, China
Yuyao People's hospital
Yuyao, Zhejiang, China
Start Date
April 1, 2024
Primary Completion Date
September 1, 2025
Completion Date
December 1, 2025
Last Updated
April 19, 2024
400
ESTIMATED participants
Zonisamide
DRUG
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
NCT05015868
NCT03054961
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03446664