Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-12 @ 4:55 AM
Study NCT ID:
NCT06967012
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2025-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
Sponsor:
Affiliated Hospital of Nantong University
Organization:
Study Overview
Official Title:
Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-11
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:
This study primarily aims to assess the efficacy and safety of zonisamide when used as an adjunctive therapy for focal epilepsy. The main questions it aims to answer are:
1. Does the frequency of epileptic seizures decrease after oral zonisamideļ¼ and does it improve cognitive function?
2. Are there any treatment-emergent adverse events associated with oral administration of zonisamide?
1. Does the frequency of epileptic seizures decrease after oral zonisamideļ¼ and does it improve cognitive function?
2. Are there any treatment-emergent adverse events associated with oral administration of zonisamide?
Detailed Description:
This study primarily focuses on zonisamide, a drug originally developed as an antiepileptic and now used as an adjunctive treatment for focal epilepsy. Focal epilepsy is caused by abnormal electrical discharges in a specific area of the brain, which can lead to sudden loss of consciousness or muscle spasms. The main content of the study can be summarized as follows:
1. Research Purpose: To evaluate the efficacy and safety of zonisamide as an adjunctive treatment for focal epilepsy, especially for drug-resistant focal epilepsy.
2. Study Design: This is an open-label, observational study without a control group, planning to recruit 30 patients aged 1-14 years who have been stably taking one antiepileptic drug in the past 4 weeks but with poor results, and are now being considered for zonisamide treatment.
3. Treatment Plan: Patients will receive a gradually increasing dose of zonisamide, starting at 2 mg/kg/day and titrating up to 6 mg/kg/day, followed by a maintenance dose of 4-6 mg/kg/day depending on the patient's condition.
4. Effectiveness Evaluation: The efficacy of zonisamide is mainly assessed by comparing the change in seizure frequency before and after treatment and the proportion of patients whose seizure frequency is reduced by more than 50%.
5. Safety Assessment: The safety of zonisamide is assessed through physical examinations, weight monitoring, vital sign monitoring, and laboratory tests (including liver and kidney function and CBC).
6. Statistical Methods: Data analysis will be performed using SAS 9.4 statistical software, incorporating both descriptive and inferential statistics to assess the statistical significance of treatment effects.
7. Research Duration: August 1, 2024-July 31, 2027. This study is significant for exploring the potential of zonisamide as a new treatment plan, especially in combating epilepsy seizures that are difficult to control with traditional drugs.
1. Research Purpose: To evaluate the efficacy and safety of zonisamide as an adjunctive treatment for focal epilepsy, especially for drug-resistant focal epilepsy.
2. Study Design: This is an open-label, observational study without a control group, planning to recruit 30 patients aged 1-14 years who have been stably taking one antiepileptic drug in the past 4 weeks but with poor results, and are now being considered for zonisamide treatment.
3. Treatment Plan: Patients will receive a gradually increasing dose of zonisamide, starting at 2 mg/kg/day and titrating up to 6 mg/kg/day, followed by a maintenance dose of 4-6 mg/kg/day depending on the patient's condition.
4. Effectiveness Evaluation: The efficacy of zonisamide is mainly assessed by comparing the change in seizure frequency before and after treatment and the proportion of patients whose seizure frequency is reduced by more than 50%.
5. Safety Assessment: The safety of zonisamide is assessed through physical examinations, weight monitoring, vital sign monitoring, and laboratory tests (including liver and kidney function and CBC).
6. Statistical Methods: Data analysis will be performed using SAS 9.4 statistical software, incorporating both descriptive and inferential statistics to assess the statistical significance of treatment effects.
7. Research Duration: August 1, 2024-July 31, 2027. This study is significant for exploring the potential of zonisamide as a new treatment plan, especially in combating epilepsy seizures that are difficult to control with traditional drugs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: