Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 drugClinical 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 patients actual condition
Detailed Description:
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 patients 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 firstthird 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
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 patients 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 firstthird 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None