Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01118962

SP0962

2014-004375-23 (EudraCT Number)

Details and patient eligibility

About

The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.

Enrollment: 39 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject completed the SP0961 (NCT01118949) study
• Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator

Exclusion criteria

• Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Lacosamide

Experimental group

Description:

Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

Treatment:

Drug: Lacosamide