Status:
COMPLETED
Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures and subjects who are temporarily unable to take oral LEV, may require alternative routes of administration....
Eligibility Criteria
Inclusion
- Adult
- in- or out-subjects suffering from partial onset seizures according to the ILAE classification of Epileptic Seizures;
- intake of levetiracetam as an adjunctive antiepileptic oral treatment in addition to one or two antiepileptic drugs (AED).
Exclusion
- Had problems of venous accessibility;
- showed safety issues related to the administration of one of the concomitant AEDs requiring medical intervention;
- clinically significant ECG/lab abnormalities;
- administered vigabatrine;
- administered felbamate for less than 18 months;
- had contraindication to any component of the study medication treatment as IV formulation or known allergic reaction to or intolerance of pyrrolidone derivatives.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00610454
Start Date
June 1 2004
End Date
August 1 2004
Last Update
December 6 2013
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