NCT00910247

Eslicarbazepine Acetate Monotherapy Long Term Study

Long Term Eslicarbazepine Acetate Extension Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a long term, open-label, safety extension study in subjects with partial onset seizures.

Detailed description

This is a long term, multicenter, open-label, safety extension study in subjects with partial onset seizures who have just completed, discontinued, or exited the 18-week treatment phase of Protocols 093-045 or 093-046. The initial study duration is 1 year with the option of continuing study drug treatment post 1 year until a subject discontinues study, the study drug becomes clinically available in the subject's locale, or the sponsor terminates the study drug clinical development program. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Eslicarbazepine acetate	800 to 2400 mg once daily (QD)

Timeline

• Start date: 2009-08-01
• Primary completion: 2017-04-15
• Completion: 2017-04-15
• First posted: 2009-05-29
• Last updated: 2018-07-17
• Results posted: 2018-07-17

Locations

122 sites across 6 countries: United States, Bulgaria, Canada, Czechia, Serbia, Ukraine