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Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275925
First Posted: January 12, 2006
Last Update Posted: November 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275925


Locations
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, Russian Federation
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00275925     History of Changes
Other Study ID Numbers: CTRI476BRU01
First Submitted: January 11, 2006
First Posted: January 12, 2006
Last Update Posted: November 30, 2007
Last Verified: November 2007

Keywords provided by Novartis:
partial epilepsy, oxcarbazepine, adults

Additional relevant MeSH terms:
Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Oxcarbazepine
Carbamazepine
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents