Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures

UCB

Status and phase: Completed; Phase 3

Conditions: Partial-onset Seizures; Epilepsy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01832038

EP0009

Details and patient eligibility

About

The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]

Enrollment: 473 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]

Exclusion criteria

• Subjects who withdrew from EP0008 [NCT01710657]

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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473 participants in 1 patient group

Lacosamide

Experimental group

Description:

Lacosamide treatment of 100 - 400 mg/day for long-term

Treatment:

Drug: Lacosamide