NCT06374966尚未招募不适用
Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy
Second Affiliated Hospital, School of Medicine, Zhejiang University10 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Effective rate at 6 months of treatment
研究概览
简要总结
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.
详细描述
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the International League Against Epilepsy 2017 diagnostic criteria for epilepsy; and the patient's seizures can be clearly classified as partial seizures according to the seizure classification proposed by the International League Against Epilepsy, including simple partial seizures, complex partial seizures, and secondary generalised seizures;
- •Be greater than or equal to 2 years of age;
- •Have been on antiepileptic medication, and during the 4-week period of the retrospective baseline period, the patient did not medication adjustments and had at least 2 seizures greater than or equal to 2 seizures per 4-week period;
- •The patient demonstrated good compliance and was able to complete the scale assessment and record the epilepsy diary on his/her own or with the assistance of a parent;
- •The informed consent form was signed and dated by the patient or a parent or legal guardian.
排除标准
- •Patients who are allergic to zonisamide ;
- •CT or MRI suggestive of progressive intracranial tumours;
- •Severe mental retardation or severe psychiatric disorders;
- •Patients suffering from serious underlying diseases that can affect brain function, such as heart disease, liver disease, renal disease, haematological disorders, malignant tumours, and patients who are immunocompromised;
- •Ultrasound suggestive of renal stones 6) Pregnant or breastfeeding
研究组 & 干预措施
Patients with focal epilepsy
who using zonisamide as an add-on anti-seizure drug
干预措施: Zonisamide (Drug)
结局指标
主要结局
Effective rate at 6 months of treatment
时间窗: 6 months
Effective definition: achievement of clinical seizure freedom or \>50% reduction in seizure frequency
次要结局
- Incidence of side effects(6 months)
- Effective rate at 3 months of treatment(3 months)
- Total time to treatment failure(6 months)
研究者
研究点 (10)
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