Status:
COMPLETED
Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy
Lead Sponsor:
UCB Pharma
Conditions:
Generalized Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experi...
Eligibility Criteria
Inclusion
- Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures. The discrimination between IC and IIE is not requested for inclusion.
- Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.
- Subjects with a confirmed diagnosis of epilepsy.
- Male/female subjects (≥16 years).
Exclusion
- History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
- History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. \< 20 minutes, with or without function regained between 2 ictal events.
- History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00150735
Start Date
June 1 2002
End Date
July 1 2005
Last Update
November 26 2013
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