Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Epilepsy, Partial Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275925
• Other study ID #: CTRI476BRU01
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2006
• Last updated: November 29, 2007
• Start date: December 2005
• Est. completion date: March 2007

Study information

• Verified date: November 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2007
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy, Partial Seizures
• Seizures

Intervention

Drug:
• Oxcarbazepine

Locations

Country	Name	City	State
Russian Federation	Epilepsy Department of the Moscow Research Institute of Psychiatry	Moscow
Russian Federation	Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University	Moscow
Russian Federation	Neurology and Neurosurgery Department of the Russian State Medical University	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	Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy	Moscow
Russian Federation	Epilepsy Department of the V.M. Bekhterev Sant-Petersburg Psychoneurology Institute	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epileptic activity at electroencephalography in rest
Primary	Flash light and hyperventilation test with electroencephalography
Primary	Frequency of epileptic episodes according to patient's diary
Primary	Electrocardiogram analysis for rhythm and conduction
Primary	Blood test for sodium, hepatic enzymes and blood cells
Secondary	Quality of Life assessment at baseline, last visit
Secondary	Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in adult patients with partial seizures
Secondary	Rate of patients with total and partial control of epilepsy
Secondary	Rate of patients requiring additional antiepileptic drugs