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

UCB Pharma25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

LevetiracetamDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

safety and tolerability of levetiracetam after switching from oral formulation to 15-minute IV infusion during repeated dosing (4 days b.i.d.)

Time frame: Adverse events after each infusion

Data from ClinicalTrials.gov

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