Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures

UCB

Status and phase

Completed

Phase 2

Conditions

Epilepsy

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00610454

N01166

Details and patient eligibility

About

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. The purpose of this trial was to evaluate the safety and tolerability of 1000 to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same oral dose.

Enrollment

25 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.