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A post marketing surveillance study evaluating effectiveness and tolerability of Trioptal® (Oxcarbazepine) in patients with generalized tonic-clonic seizures as monotherapy in routine clinical practice in India

A prospective, open-label, multicentre, non-comparative, observational post marketing surveillance study evaluating effectiveness and tolerability of Trioptal® (Oxcarbazepine) in patients with generalized tonic-clonic seizures as monotherapy in routine clinical practice in India

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2012/12/003238
Enrollment
500
Registered
2012-12-18
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- Patients with generalized tonic-clonic seizures.

Interventions

Intervention1: Oxcarbazepine: dosage : 600 mg/day (8-10 mg/kg/day) given in 2 divided doses.

Sponsors

Novartis India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a history of generalized tonic-clonic seizures.

Exclusion criteria

Exclusion criteria: Contraindications like hypersensitivity to the active substance or to any of the excipients mentioned in the local prescribing information for Trioptal.

Design outcomes

Primary

MeasureTime frame
Percent reduction from baseline in number of seizures per month and percent responders. â?¢ Physicians and subjects global evaluation of improvement in seizure severity.Timepoint: 6 months.—

Secondary

MeasureTime frame
â?¢ Evaluate the tolerability of Oxcarbazepine (Trioptal®) during monotherapy based on reported adverse events and reported serious adverse eventsTimepoint: 6 months.;â?¢ Physicians and Subjects global evaluation of tolerability.Timepoint: 6 months.—

Countries

India

Contacts

Public ContactDr Apurva Gawai

Novartis India Ltd.

apurva.gawai@novartis.com022-24958594

Outcome results

None listed

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