Status:
COMPLETED
Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy, Partial
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
Brief Summary
clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects with partial seizures.
Eligibility Criteria
Inclusion
- subject suffering from partial onset seizures, whether or not secondarily generalized,
- presence of the following during the eight weeks of the historical baseline period: at least eight partial seizures (type IA, IB or IC) with or without secondary generalization.
- subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (AEDs).
- subject who has been exposed to at least one classical AEDs,
- CT scan or MRI performed within the last 2 years and free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease.
Exclusion
- history of status epilepticus within three months prior to the Selection visit,
- subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries),
- use of any medication (other than the concomitant AED) that influences the central nervous system (CNS) unless on a stable regimen for at least 1 month prior to the Selection visit. Antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed. Intermittent benzodiazepines are allowed as long as the frequency is not greater than one single administration per week for at least 3 months prior to the Selection visit. Neuroleptics and Traditional Chinese AEDs are not allowed.,
- history or presence of pseudoseizures,
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00152373
Start Date
July 1 2004
End Date
May 1 2005
Last Update
December 3 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.