Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Phase 4

Completed

• Conditions: Epilepsy, Partial Seizures

• Registration Number: NCT00275925
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Study Completion: 2007-03
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-29
• Last Update Posted: 2007-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Neurology and Neurosurgery Department of the Russian State Medical University; 🇷🇺 Moscow, Russian Federation

Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University; 🇷🇺 Moscow, Russian Federation

Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy; 🇷🇺 Moscow, Russian Federation

Epilepsy Department of the Moscow Research Institute of Psychiatry; 🇷🇺 Moscow, Russian Federation

Neurology Department of I.M. Sechenov Moscow Medical Academy; 🇷🇺 Moscow, Russian Federation

Neurology Department of Pediatric faculty of the Russian State Medical University; 🇷🇺 Moscow, Russian Federation

Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute; 🇷🇺 Saint Petersburg, Russian Federation