NCT00530855

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

A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide	50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years

Timeline

• Start date: 2008-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2007-09-18
• Last updated: 2018-07-18
• Results posted: 2015-06-03

Locations

108 sites across 9 countries: United States, Australia, Canada, Denmark, Germany, Italy, Poland, Spain, United Kingdom