Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

UCB

Status and phase: Completed; Phase 3

Conditions: Partial Epilepsies

Treatments: Drug: lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00522275

2014-004398-18 (EudraCT Number)

SP0756

Details and patient eligibility

About

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy

Enrollment: 308 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of parent clinical trial for treatment of partial seizures

Exclusion criteria

• Receiving any study drug or experimental device other than lacosamide
• Meets withdrawal criteria for parent trial or 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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308 participants in 1 patient group

Lacosamide

Experimental group

Description:

Up to 800 mg/day lacosamide (flexible dosing)

Treatment:

Drug: lacosamide