CTRI/2024/06/068290
Not yet recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
- Sponsor
- ot applicable
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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