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Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00275925
First received: January 11, 2006
Last updated: November 29, 2007
Last verified: November 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275925

Locations
Russian Federation
Neurology Department of I.M. Sechenov Moscow Medical Academy
Moscow, Russian Federation
Epilepsy Department of the Moscow Research Institute of Psychiatry
Moscow, Russian Federation
Neurology Department of the Moscow region Research Institute named after M.F. Vladimirskiy
Moscow, Russian Federation
Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University
Moscow, Russian Federation
Neurology Department of Pediatric faculty of the Russian State Medical University
Moscow, Russian Federation
Neurology and Neurosurgery Department of the Russian State Medical University
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

No publications provided

ClinicalTrials.gov Identifier: NCT00275925     History of Changes
Other Study ID Numbers: CTRI476BRU01
Study First Received: January 11, 2006
Last Updated: November 29, 2007
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Novartis:
partial epilepsy, oxcarbazepine, adults

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013