Phase 3 N=99 Randomized Double-blind Treatment

Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

Partial Onset Seizures

Bottom Line

View on ClinicalTrials.gov: NCT00975715 ↗

Enrolled (actual)

Serious AEs

2.0%

Results posted

Jan 2014

Primary outcome: Primary: Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group — -2.85; 14.82 percentage change per 28 days

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TRI476 (Drug); Placebo to TRI476 (Drug); Benzodiazepines (Drug)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group	-2.85; 14.82	—
SECONDARY Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group	65.58; 90.61; 45.40; 98.73	—
SECONDARY Percent of Participants With Response During Double-blind Phase, by Treatment Group	23.4; 3.9	—
SECONDARY Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type	-9.73; -16.89; -6.86; 30.59; -29.54; 12.11	—
SECONDARY Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group	9; 2; 8; 2; 8; 6	—

Summary

This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.

Eligibility Criteria

Inclusion Criteria

Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg.
A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epilepsy (ILAE) Classification, as modified in 1981).

Exclusion Criteria

A document history of generalized status epileptics in the past 6 months.
Seizures having a metabolic, neoplastic, or active infectious origin.

Other protocol-defined inclusion/exclusion criteria may apply

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Data sourced from ClinicalTrials.gov (NCT00975715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.