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Study on the Effectiveness and Safety of Once-Daily Brivaracetam for Drug-Resistant Focal Onset Epilepsy

Post approval observational study for the assessment of effectiveness and safety of once a daily sustained release formulation of BRivarACetam in drug rEsisTance focal onset epilepsy - BRACkET

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/070210
Enrollment
6000
Registered
2024-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Torrent Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female patients with: 1. Partial onset seizures in patients 16 years of age and older 2. Patients diagnosed with epilepsy and treated with Brivaracetam SR tablets

Exclusion criteria

Exclusion criteria: Hypersensitive to Brivaracetam SR tablets or any of the ingredients in medicine

Design outcomes

Primary

MeasureTime frame
1. Switching pattern amongst ASMs 2. Reduction in seizure frequency at baseline 3. Greater than or equal to 50 percent Responder rate 4. Seizure freedomTimepoint: Baseline and 12 weeks—

Secondary

MeasureTime frame
To assess the safety profile of BRV SR in patients with FoS with or without secondary generalized tonic- clonic seizuresTimepoint: At 12 weeks—

Countries

India

Contacts

Public ContactKrishnaPrasad Korukonda

Department of Neurology, Brain and nerve Clinic

bhagyadhan30@gmail.com8980011822

Outcome results

None listed

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