Status:
COMPLETED
Eslicarbazepine Acetate Monotherapy Long Term Study
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
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 0...
Eligibility Criteria
Inclusion
- Subject Inclusion/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.
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2017
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00910247
Start Date
August 1 2009
End Date
April 15 2017
Last Update
July 17 2018
Active Locations (122)
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1
Neurology Clinic, P.C.
Northport, Alabama, United States, 35476
2
21st Century Neurology, a division of Xenoscience, Inc.
Phoenix, Arizona, United States, 85004
3
Clinical Research Consortium-Arizona
Phoenix, Arizona, United States, 85004
4
Arizona Neurological Institute
Sun City, Arizona, United States, 85351