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Brivaracetam drug in treating epilepsy

Treatment of Focal Seizures Patients with Brivaracetam through a Multicenter, Real-World Study: Case Cohort Analysis - ROBUST

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/06/068495
Enrollment
2100
Registered
2024-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset

Interventions

Intervention1: Brivaracetam Tablets: Dose: Brivaracetam 25 mg, 50 mg, 100 mg, 200 mg oral tablets. Frequency: Will be determined by treating investigator. The tablets will be administered orally and

Sponsors

Torrent Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male or female patients with partial onset seizures with or without secondary generalization in patients 18 years of age and older with epilepsy. 2) Known cases brivaracetam receiving therapy for more than equal to 2 weeks.

Exclusion criteria

Exclusion criteria: Patients allergic to brivaracetam or any of the ingredients in medicine.

Design outcomes

Primary

MeasureTime frame
Change in Seizure FrequencyTimepoint: 4 weeks and 12 weeks

Secondary

MeasureTime frame
Clinicians Global Impression – Efficacy Index (CGI-EI)Timepoint: 4 weeks and 12 weeks;Demographic patternTimepoint: Baseline;Other Anti-epileptic drugs (AEDs) used along with BRV.Timepoint: Baseline, 4 weeks and 12 weeks;Patient’s treatment acceptabilityTimepoint: 4 weeks and 12 weeks;Prevalence of other co-morbid conditions along with Focal EpilepsyTimepoint: Baseline;Quality of lifeTimepoint: 4 weeks and 12 weeks;Responders RateTimepoint: 4 weeks and 12 weeks;Safety assessments in terms of AEsTimepoint: 4 weeks and 12 weeks;Seizure FreedomTimepoint: 4 weeks and 12 weeks

Countries

India

Contacts

Public ContactDr Krishnaprasad K

Karunesh Neuro and Spine SUrgical Hospital

drnikunjgodhani@proton.me9825941321

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026