Status:
COMPLETED
Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy, Tonic-clonic
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs
Eligibility Criteria
Inclusion
- Subjects with a confirmed diagnosis of epilepsy.
- Subjects having experienced in the past 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
- Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.
Exclusion
- Need for an additional AED.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00150787
Start Date
July 1 2003
End Date
November 1 2005
Last Update
November 26 2013
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