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

Trial Evaluating the Safety and Tolerability of Levetiracetam Intravenous 15-minute Infusion, Administered in b.i.d. Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 65 Years Suffering From Partial Onset Seizures

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00610454

Enrollment

Registered

2008-02-08

Start date

2004-06-30

Completion date

2004-08-31

Last updated

2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Levetiracetam, Keppra

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. 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.

Interventions

DRUGLevetiracetam

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026