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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.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00610454
First received: January 18, 2008
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

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
Epilepsy
 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:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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)
  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610454

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

Publications:

ClinicalTrials.gov Identifier: NCT00610454     History of Changes
Other Study ID Numbers: N01166
Study First Received: January 18, 2008
Last Updated: September 14, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Levetiracetam
Keppra

Additional relevant MeSH terms:
Epilepsy
Stress, Psychological
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms
Etiracetam
Piracetam
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013