Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Novartis

Status and phase: Completed; Phase 4

Conditions: Epilepsy, Partial Seizures

Treatments: Drug: Oxcarbazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00275925

CTRI476BRU01

Details and patient eligibility

About

This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• males and females, 18 - 70 years of age;
• diagnosis of epilepsy, partial seizures;
• ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous therapy with antiepileptic drugs

Exclusion criteria

• progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
• non-epileptic seizures;
• drug or alcohol dependence during a year prior to screening;

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)