TRIOX: A post marketing study on the effects and safety of Trioptal in patients with newly diagnosed epilepsy

The prospective, open-label, multicentre, non-comparative, observational post-marketing surveillance study evaluating efficacy and tolerability of TRIoptal® (OXcarbazepine) in children and adolescents with newly diagnosed partial seizures or generalized tonic-clonic seizures as monotherapy in routine clinical practice

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001239

Enrollment

500

Registered

2010-12-03

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

None listed

Interventions

Intervention1: Oxcarbazepine: 24 weeks treatment. Dose as per weight (10mg/kg/day) Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female children & adolescents between 1 month to 18 years of age (both inclusive) with newly diagnosed epilepsy of the following types: 2.Partial seizures (including the seizure subtypes of simple and complex partial seizures, and partial seizures evolving to secondarily generalized seizures) or Generalized tonic clonic seizures 3. Patients or their parent/legally-authorized guardian having given written, informed consent and/or assent after the nature of the trial had been fully explained (according to the local legal regulatory requirements)

Exclusion criteria

Exclusion criteria: 1.Age less than 1 month or greater than 18 years; 2.Patients with evidence of severe or unstable physical illness or medical condition which would prevent them from participating in the clinical trial; 3.Any clinically significant abnormal laboratory findings during screening which remain abnormal upon repeated measurement; 4.Known hypersensitivity to Oxcarbazepine or any of the components in the formulation; 5. Any psychiatric coexistent illness that may affect the patient?s compliance with study procedures; 6. Patients with other indications than partial seizures, or generalized tonic-clonic seizures; 7. Parents or Guardians who are not willing to sign the Informed Consent form. 8. Females of child bearing potential who are planning to become pregnant or who are pregnant.

Design outcomes

Primary

Measure	Time frame
Seizure Frequency: Reduction is seziure frequency from baseline to end of treatment.Timepoint: From baseline to end of study at 24 weeks	—

Secondary

Measure	Time frame
Tolerability of the drug: Adverse Events and Serious Adverse EventsTimepoint: From enrollment to end of study at 24 weeks	—

Countries

India

Contacts

Public ContactDr Sameer Guliani

Medical Advisor

sameer.guliani@novartis.com02224958590

Outcome results