Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

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. Identifier: NCT00275925
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : November 30, 2007
Information provided by:

January 11, 2006
January 12, 2006
November 30, 2007
December 2005
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  • 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
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Complete list of historical versions of study NCT00275925 on Archive Site
  • 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
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Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures
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
This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy, Partial Seizures
Drug: Oxcarbazepine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2007
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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.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Russian Federation
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Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP