Factors associated with favorable response to vigabatrin children with epilepsy.

Post-marketing surveillance to determine sociodemographic and clinical variables associated with favorable response to vigabatrin in children with West syndrome - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/03/082665

Enrollment

100

Registered

2025-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes

Interventions

Intervention1: Vigabatrin: Oral vigabtrin sachet at 50 mg/kg/day daily in two divided doses for 12 weeks Control Intervention1: Not applicable: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: Children with diagnosis of West syndrome Having daily at least one epileptic spasms for last seven days

Exclusion criteria

Exclusion criteria: Children receiving ACTH or oral prednisolone History of previous documented allergy to vigabtarin

Design outcomes

Primary

Measure	Time frame
Resolution of epileptic spasmsTimepoint: At 12 weeks after starting oral vigabtarin	—

Secondary

Measure	Time frame
Frequency of reduction of weekly epileptic spasmsTimepoint: At 12 weeks after starting oral vigabtarin as comapred to baseline	—

Countries

India

Contacts

Public ContactPrateek Kumar Panda

AIIMS, Rishikesh

drprateekpanda@gmail.com9650149735

Outcome results

None listed

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