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Differnce between syrups and tablets of common antiepileptic drugs in children

Comparative effect of liquid and solid oral formulations of common antiepileptic drugs on the management of epilepsy in children - CELSAE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/12/007602
Enrollment
240
Registered
2016-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Epilepsy

Interventions

Control Intervention1: Liquid formulations: Phenytoin oral suspension (125mg/5ml), 5ml once daily Phenobarbitone oral syrup (30mg/5ml), 15ml once daily Carbamazepine oral suspension (100mg/5ml), 10ml

Sponsors

Jawaharlal Institute of Postgraduate Medical Education Research JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children with partial /tonic-clonic/absence seizures or combinations of seizures 2. Children newly diagnosed as having epilepsy or on maintenance therapy with phenytoin, carbamazepine, valproate and phenobarbitone, either alone or in combination.

Exclusion criteria

Exclusion criteria: 1.Patients with special seizures 2.Very sick children with other co-morbid conditions

Design outcomes

Primary

MeasureTime frame
1.Efficacy assessments - Seizure frequency/week 2.Safety and tolerability assessments 3.Child and caregiver preferenceTimepoint: At the end of 3rd and 6th months of both oral solid and liquid formulations—

Secondary

MeasureTime frame
1.Estimation of plasma drug levels (TDM) 2.Responders and non-responders Timepoint: At the end of 3rd and 6th months of both oral solid and liquid formulations—

Countries

India

Contacts

Public ContactMr Ravi Prasad Nidanapu

JIPMER

ravipisces19@gmail.com9488317109

Outcome results

None listed

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