Eslicarbazepine Acetate Monotherapy Long Term Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00910247
First received: May 27, 2009
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Epilepsy
Drug: Eslicarbazepine acetate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long Term Eslicarbazepine Acetate Extension Study

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • Number and percentage of subjects with treatment emergent adverse events [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations [ Time Frame: 1, 3, 6, 9, and 12 Months ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with normal baseline sodium reaching blood sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L [ Time Frame: 1, 3, 6, 9, and 12 Months ] [ Designated as safety issue: No ]
  • Proportion (%) of subjects with increase of body weight ≥7% [ Time Frame: 1, 3, 6, 9, and 12 Months ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with orthostatic effects. [ Time Frame: 1, 3, 6, 9, and 12 Months ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with QTc-F changes (in categories) from baseline. [ Time Frame: 1, 3, 6, 9, and 12 Months ] [ Designated as safety issue: No ]
  • Proportion (%) of events in each classification of the Columbia Suicide Severity Rating Scale (C SSRS). [ Time Frame: 1, 3, 6, 9, and 12 Months ] [ Designated as safety issue: No ]
  • Time on eslicarbazepine acetate monotherapy. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Change in seizure frequency from baseline. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Responder rate (proportion [%] of subjects with a ≥50% reduction of seizure frequency from baseline). [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Proportion (%) of subjects that are seizure-free during study [ Time Frame: 1, 3, 6, 9, and 12 Months ] [ Designated as safety issue: No ]
  • Completion rate (% of subjects completing the one year treatment) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Treatment retention time (time to withdrawal due to lack of efficacy or adverse events) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Change in total score from baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31). [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Change in total score from baseline in Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Change in total score from baseline in MADRS in those subjects with a MADRS score of ≥14 at screening [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Completion rate (% of subjects completing each visit post-one year). [ Time Frame: 3 month intervals beyond one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 348
Study Start Date: August 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eslicarbazepine acetate
Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD
Drug: Eslicarbazepine acetate
800 to 2400 mg once daily (QD)
Other Names:
  • SEP-0002093
  • BIA 2-093

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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910247

  Show 122 Study Locations
Sponsors and Collaborators
Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00910247     History of Changes
Other Study ID Numbers: 093-050
Study First Received: May 27, 2009
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Sunovion:
Seizures
Epilepsy
Anticonvulsant
Monotherapy
Epilepsy with simple or complete partial onset seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 20, 2014