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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2004-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy

Keywords

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Levetiracetam Keppra

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Levetiracetam

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

References

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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.

Reference Type BACKGROUND

PMID: 17326794 (View on PubMed)

Other Identifiers

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N01166

Identifier Type: -

Identifier Source: org_study_id