CTRI/2024/06/068290
尚未招募
不适用
Case cohort, Cross–sectional study to Assess clinical efficacy and safety of Brivaracetam in patients with primary GENERALised tonic-clonic seizures in outpatient settings of India
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- 1) Percent change in Seizure frequency every month at 12W based on patient diary.
概览
简要总结
This is an Investigator initiated, case cohort, cross-sectional, multi-center, single arm, open-label, clinical study to evaluate clinical efficacy and safety of Brivaracetam as initial add-on therapy in difficult-to-treat pGTCS receiving valproate or levetiracetam monotherapy.
The study drug is Brivaracetam oral tablets of doses 25 mg, 50 mg, 75 mg, 100 mg.
Total cases will be 150 patients across India.
Study visits: Baseline, Week 4, Week 12.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than or equal to 1 unprovoked generalized tonic clonic seizures showing nonresponsiveness to Valproate monotherapy upto 1500mg per day, with less than equal to 50% change in seizure frequency for every month and had brivaracetam being added to valproate.
- •Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than equal to 1 unprovoked generalized tonic clonic seizures showing nonresponsiveness to Levetiracetam monotherapy upto 1000mg per day, with less than equal to 50% change in seizure frequency for every month and had brivaracetam being added to levetiracetam.
- •Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than equal to 1 unprovoked generalized tonic clonic seizures showing behavioural adverse effects with levetiracetam and requiring treatment replacement with brivaracetam.
- •Clinical cases receiving brivaracetam for PGTCS with follow-up data for 12 weeks.
排除标准
- •Hypersensitivity to Brivaracetam 2) Cases with structural lesion, diagnosis of Lennox Gastaut Syndrome, JAE, CAE and,or JME.
- •Lack of EEG corroboration 4) Cases with preceding or pre existing unstable medical, psychiatric or cardiovascular condition that could jeopardize or would compromise the subjects ability to participate in this study.
- •Cases without 12 weeks follow up data.
结局指标
主要结局
1) Percent change in Seizure frequency every month at 12W based on patient diary.
时间窗: Baseline, 4 weeks and 12 weeks
2) Percent change in Seizure frequency from combined baseline to 12W for patients with GTCS.
时间窗: Baseline, 4 weeks and 12 weeks
次要结局
- More than equal to 50% responder rate in PGTCS frequency per month(Baseline, 4 and 12 weeks)
- Seizure freedom rate(12 weeks)
- Physician Assessment of Effectiveness(12 weeks)
- Adverse event rate for treatment naïve or uncontrolled cases(4 weeks, 12 weeks)
研究者
Dr Nandan Yardi
Yardi Hospital
研究点 (4)
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