Long Term Eslicarbazepine Acetate Extension Study

Sumitomo Pharma America, Inc.120 sites in 1 country274 target enrollmentAugust 2009

ConditionsEpilepsy

InterventionsEslicarbazepine acetate

DrugsEslicarbazepine acetate

Overview

Phase: Phase 3
Intervention: Eslicarbazepine acetate
Conditions: Epilepsy
Sponsor: Sumitomo Pharma America, Inc.
Enrollment: 274
Locations: 120
Primary Endpoint: Number and Percent of Subjects With Treatment Emergent Adverse Events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

April 15, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible.
•Subject must give written informed consent prior to participation in the study. For subjects \<18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (≤65 years of age) must also sign the "Women of Childbearing Potential" Addendum.
•Subjects must, in the opinion of the Investigator (with consultation with Medical Monitor as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
•If female subject, must continue the accepted method of birth control defined in Protocols 093-045 or 093-046 for the duration of this study as well
•Criterion for Continuation into the Post 1 year Part of Study:
•For subjects to continue into the post 1 year part of the study, subjects must, in the opinion of the Investigator (with consultation with Medical Monitor, as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.

Arms & Interventions

eslicarbazepine acetate

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Intervention: Eslicarbazepine acetate

Outcomes

Primary Outcomes

Number and Percent of Subjects With Treatment Emergent Adverse Events

Time Frame: One year

Number and percent of subjects with treatment emergent adverse events

Secondary Outcomes

Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L(1 year)
Change in Seizure Frequency From Baseline.(Month 12 from baseline)
Number and Percentage of Subjects With Orthostatic Effects.(1 year)
Percentage of Subjects That Are Seizure-free During Study(1 year)
Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations(1 year)
Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.(Baseline, Month 12)
Percentage of Subjects With Increase of Body Weight ≥7%(1 year)
Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).(1 year)
Time on Eslicarbazepine Acetate Monotherapy.(One year)
Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).(One year)
Completion Rate (% of Subjects Completing the One Year Treatment)(One year)
Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).(baseline and Month 12)
Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).(1 year)
Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening(baseline and Month 12)
Completion Rate (% of Subjects Completing Each Visit Post-one Year).(post 1 year)
Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)(One year)