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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
January 11, 2006
January 12, 2006
November 30, 2007
December 2005
Not Provided
  • 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
Not Provided
Complete list of historical versions of study NCT00275925 on ClinicalTrials.gov 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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Epilepsy, Partial Seizures
Drug: Oxcarbazepine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2007
Not Provided

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)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT00275925
CTRI476BRU01
Not Provided
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Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2007

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