Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data

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Detailed Description

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A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Conditions

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Partial Epilepsies Partial Onset Seizures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lacosamide

Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)

Group Type EXPERIMENTAL

lacosamide

Intervention Type DRUG

Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).

Interventions

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lacosamide

Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).

Intervention Type DRUG

Other Intervention Names

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Vimpat

Eligibility Criteria

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Inclusion Criteria

* Eligible subjects who participated in SP925 \[NCT00655551\] for treatment of partial-onset seizures

Exclusion Criteria

* Receiving any study drug or experimental device other than lacosamide
* Meets withdrawal criteria for parent study SP925 \[NCT00655551\]
* Experiencing ongoing serious adverse event

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No