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

UCB

Status and phase: Completed; Phase 2

Conditions: Partial Epilepsies

Treatments: Drug: lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00552305

SP0615

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: 370 patients

Sex: All

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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370 participants in 1 patient group

Lacosamide

Experimental group

Description:

50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing

Treatment:

Drug: lacosamide