Status:
COMPLETED
Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepi...
Eligibility Criteria
Inclusion
- Diagnosis of epilepsy (all types of seizures) was made during the past year
- Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
- Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
Exclusion
- Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
- Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
- Pregnant or lactating women
- Presence of known pseudoseizures within the last year
- Uncountable seizures (clusters) or history of convulsive status epilepticus
- Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
- History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors
- Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
1701 Patients enrolled
Trial Details
Trial ID
NCT00175903
Start Date
February 1 2005
End Date
October 1 2007
Last Update
March 17 2015
Active Locations (229)
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1
Adelaide, Australia
2
Bedford Park, Australia
3
Brisbane, Australia
4
Cairns, Australia