Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00275925

Purpose

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

Condition	Intervention	Phase
Epilepsy, Partial Seizures	Drug: Oxcarbazepine	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome 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 Outcome 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

Estimated Enrollment:	80
Study Start Date:	December 2005
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275925

Locations

Russian Federation
Neurology Department of I.M. Sechenov Moscow Medical Academy
Moscow, Russian Federation
Epilepsy Department of the Moscow Research Institute of Psychiatry
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, Russian Federation
Neurology Department of Pediatric faculty of the Russian State Medical University
Moscow, Russian Federation
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

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CTRI476BRU01
Study First Received:	January 11, 2006
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00275925 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Novartis:

partial epilepsy, oxcarbazepine, adults

Additional relevant MeSH terms:

Epilepsies, Partial
Tranquilizing Agents
Oxcarbazepine
Physiological Effects of Drugs
Seizures
Nervous System Diseases
Psychotropic Drugs
Central Nervous System Depressants
Central Nervous System Diseases
Antimanic Agents
Brain Diseases
Pharmacologic Actions

Signs and Symptoms
Carbamazepine
Sensory System Agents
Analgesics, Non-Narcotic
Epilepsy
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010