Status:
COMPLETED
Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
Lead Sponsor:
UCB Pharma SA
Conditions:
Generalized Epilepsy
Eligibility:
All Genders
4-64 years
Phase:
PHASE3
Brief Summary
An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.
Eligibility Criteria
Inclusion
- Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
- Subjects who were/are suffering from primary generalized (type II) epileptic seizures
- Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected
Exclusion
- Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol
- Concomitant use of any drug with possible central nervous system effects unless at a stable dose
- Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00150748
Start Date
November 1 2001
End Date
July 1 2007
Last Update
July 29 2020
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