Comparing effect of Brivaracetam and Levetiracetam in controlling number of seizures in epileptic children

Supplementary efficacy of Brivaracetam and Levetiracetam on frequency of seizures among epileptic children aged 1 to less-than-18 years- An open labelled, randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080718

Enrollment

150

Registered

2025-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Brivaracetam: In children who are on one more more anti-seizure medications, and whose seizures are not controlled on it, Brivaracetam will be added and the child will be monitored for

Eligibility

Inclusion criteria

Inclusion criteria: Children with epilepsy, not controlled with one or more ASMs aged 1 to less than 18 years.

Exclusion criteria

Exclusion criteria: 1) Children who are on therapy with Levetiracetam or Brivaracetam or have been in the last 1 month 2) Drug resistant epilepsy, secondary to progressive cerebral disease, tumors, and progressive neurodegenerative disorders. 3) Clinically significant baseline laboratory abnormalities (CBC, RFT, LFT)

Design outcomes

Primary

Measure	Time frame
To study the percentage of greater than or equal to 50% seizure reduction among children aged 1 to less than 18 years after supplementing Brivaracetam as an add on anti seizure medication compared to supplementing Levetiracetam as an add on anti seizure medication.Timepoint: The percentage of seizure reduction will be analyzed at 8 weeks after initiating the anti seizure medication.	—

Secondary

Measure	Time frame
To study the retention rates and adverse effects of Brivaracetam and LevetiracetamTimepoint: The retention rates and the adverse effects of the drugs will be studied at 8 weeks after initiating the drugs;To compare the percentage of greater than or equal to 50 % seizure reduction in focal vs generalized epilepsyTimepoint: The percentage of seizure reduction in focal & generalized epilepsy will be studied at 8 weeks after initiating the drugs;To compare the percentage of greater than or equal to 50% seizure reduction in children using two anti seizure medication vs more than two anti seizure medicationTimepoint: The comparison of seizure reduction in children using two anti seizure medications versus more than two anti seizure medications will be made at 8 weeks after initiating the drugs;To compare the percentage of greater than or equal to 50% seizure reduction at 4 weeks of intervention vs 8 weeks of interventionTimepoint: The time points are as specified in the outcome	—

Measure

Time frame

To study the retention rates and adverse effects of Brivaracetam and LevetiracetamTimepoint: The retention rates and the adverse effects of the drugs will be studied at 8 weeks after initiating the drugs;To compare the percentage of greater than or equal to 50 % seizure reduction in focal vs generalized epilepsyTimepoint: The percentage of seizure reduction in focal & generalized epilepsy will be studied at 8 weeks after initiating the drugs;To compare the percentage of greater than or equal to 50% seizure reduction in children using two anti seizure medication vs more than two anti seizure medicationTimepoint: The comparison of seizure reduction in children using two anti seizure medications versus more than two anti seizure medications will be made at 8 weeks after initiating the drugs;To compare the percentage of greater than or equal to 50% seizure reduction at 4 weeks of intervention vs 8 weeks of interventionTimepoint: The time points are as specified in the outcome

—

Countries

India

Contacts

Public ContactTamil Selvan

JIPMER

drselvantg@yahoo.com9916485716

Outcome results

None listed

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