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

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

Study Description

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

Study Design

• 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

Arms and Interventions

Outcome Measures

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 ]

Eligibility Criteria

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

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Publications:

Baulac M, Brodie MJ, Elger CE, Krakow K, Stockis A, Meyvisch P, Falter U. Levetiracetam intravenous infusion as an alternative to oral dosing in patients with partial-onset seizures. Epilepsia. 2007 Mar;48(3):589-92. doi: 10.1111/j.1528-1167.2006.00959.x. Epub 2007 Feb 22.

• ClinicalTrials.gov Identifier: NCT00610454
• Other Study ID Numbers: N01166
• First Posted: February 8, 2008
• Last Update Posted: December 6, 2013
• Last Verified: September 2009

Keywords provided by UCB Pharma:

Levetiracetam; Keppra

Additional relevant MeSH terms:

Seizures; Nervous System Diseases; Neurologic Manifestations; Levetiracetam; Anticonvulsants; Nootropic Agents