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

UCB

Status and phase: Completed; Phase 3

Conditions: Partial Onset Seizures; Partial Epilepsies

Treatments: Drug: lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00655486

2014-004384-21 (EudraCT Number)

SP0926

Details and patient eligibility

About

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

Full description

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).

Enrollment: 97 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

Lacosamide

Experimental group

Description:

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

Treatment:

Drug: lacosamide