Status:
COMPLETED
Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures
Lead Sponsor:
Novartis
Conditions:
Epilepsy, Partial Seizures
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00275925
Start Date
December 1 2005
End Date
March 1 2007
Last Update
November 30 2007
Active Locations (7)
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1
Epilepsy Department of the Moscow Research Institute of Psychiatry
Moscow, Russia
2
Neurology and Neurosurgery Department of the Moscow State Medico-stomatology University
Moscow, Russia
3
Neurology and Neurosurgery Department of the Russian State Medical University
Moscow, Russia
4
Neurology Department of I.M. Sechenov Moscow Medical Academy
Moscow, Russia