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Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy, Partial Seizures

Intervention: Oxcarbazepine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

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

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

Primary outcome:

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:

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): 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.

Locations and Contacts

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, Russian Federation

Additional Information

Starting date: December 2005
Last updated: November 29, 2007

Page last updated: August 23, 2015

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