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Trial record 1 of 1 for:    NCT00610454
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Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures

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ClinicalTrials.gov Identifier: NCT00610454
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : December 6, 2013
Information provided by:
UCB Pharma

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Levetiracetam Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2004
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610454

Sponsors and Collaborators
UCB Pharma
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
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ClinicalTrials.gov Identifier: NCT00610454    
Other Study ID Numbers: N01166
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Additional relevant MeSH terms:
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Nervous System Diseases
Neurologic Manifestations
Nootropic Agents