Official Title: “A 24-Week Prospective, Open-Label, Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Adult Patients With Partial Seizures”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Oxcarbazepine

Primary Measures

• Epileptic activity at electroencephalography in rest
• Flash light and hyperventilation test with electroencephalography
• Frequency of epileptic episodes according to patient's diary
• Electrocardiogram analysis for rhythm and conduction
• Blood test for sodium, hepatic enzymes and blood cells

Secondary Measures

• Quality of Life assessment at baseline, last visit
• Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients with partial seizures
• Rate of patients with total and partial control of epilepsy
• Rate of patients requiring additional antiepileptic drugs

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00275925

Study ID Number: CTRI476BRU01

ClinicalTrials.gov Identifier: NCT00275925

Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation