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临床试验/CTRI/2024/06/068290
CTRI/2024/06/068290尚未招募Unknown

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 - GENERAL-I

ot applicable0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
ot applicable

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1) 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.
  • 2) 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.
  • 3) 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.
  • 4) Clinical cases receiving brivaracetam for PGTCS with follow-up data for 12 weeks.

排除标准

  • 1) Hypersensitivity to Brivaracetam
  • 2) Cases with structural lesion, diagnosis of Lennox Gastaut Syndrome, JAE, CAE and,or JME.
  • 3) 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.
  • 5) Cases without 12 weeks follow up data.

研究者

发起方
ot applicable

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