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

This study has been completed.
Information provided by:
UCB Pharma Identifier:
First received: January 18, 2008
Last updated: December 5, 2013
Last verified: September 2009

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.

Condition Intervention Phase
Drug: Levetiracetam
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: June 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00610454

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications: Identifier: NCT00610454     History of Changes
Other Study ID Numbers: N01166
Study First Received: January 18, 2008
Last Updated: December 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB Pharma:

Additional relevant MeSH terms:
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on November 20, 2014