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 restFlash 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 visitTolerability 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
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