Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:00 PM
Ignite Modification Date:
2025-12-24 @ 4:00 PM
NCT ID:
NCT06374966
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 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.
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 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.
Study:
NCT06374966
Study Brief:
Protocol Section:
NCT06374966