Completed

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

What is being tested

Data Collection

Who is being recruted

Brain Diseases+1

+ Central Nervous System Diseases

+ Epilepsy

From 16 to 65 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: June 2004

See protocol details

Summary

Principal SponsorUCB Pharma

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleTrial 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

NCT00610454

Principal SponsorUCB Pharma

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesEpilepsyNervous System Diseases

Criteria

3 inclusion criteria required to participate

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).

6 exclusion criteria prevent from participating

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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers