Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)

Exclusion Criteria:

• Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)