Eslicarbazepine Acetate Monotherapy Long Term Study

NCT00910247 | Completed Phase 3 Results

• 1 other identifier: 093-050
• Study Type: interventional
• Target: 274
• Locations: 6 countries
• Sites: 122

Brief Summary

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

Conditions

Epilepsy

Keywords

Seizures; Epilepsy; Anticonvulsant; Monotherapy; Epilepsy with simple or complete partial onset seizures

Outcome Measures

Primary Outcomes (1)

• Number and Percent of Subjects With Treatment Emergent Adverse Events

  Number and percent of subjects with treatment emergent adverse events

  One year

Secondary Outcomes (16)

• Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations

  1 year

• Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L

  1 year

• Percentage of Subjects With Increase of Body Weight ≥7%

  1 year

• Number and Percentage of Subjects With Orthostatic Effects.

  1 year

• Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.

  Baseline, Month 12

Study Arms (1)

eslicarbazepine acetate

EXPERIMENTAL

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

Drug: Eslicarbazepine acetate

Interventions

Eslicarbazepine acetate DRUG

800 to 2400 mg once daily (QD)

Also known as: SEP-0002093, BIA 2-093

eslicarbazepine acetate

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (122)

Neurology Clinic, P.C.

Northport, Alabama, 35476, United States

Location

21st Century Neurology, a division of Xenoscience, Inc.

Phoenix, Arizona, 85004, United States

Location

Clinical Research Consortium-Arizona

Phoenix, Arizona, 85004, United States

Location

Arizona Neurological Institute

Sun City, Arizona, 85351, United States

Location

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

University of Arizona, Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Arkansas Neurology

Conway, Arkansas, 72034, United States

Location

K&S Professional Research Services, LLC

Little Rock, Arkansas, 72201, United States

Location

Sutter East Bay Medical Foundation

Berkeley, California, 94705, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

Location

Faculty of Physicians and Surgeons of Loma Linda University

Loma Linda, California, 92354, United States

Location

Viking Clinical Research Center

Murrieta, California, 92562, United States

Location

Viking Clinical Research

Murrieta, California, 92562, United States

Location

Northridge Neurological Research Center

Northridge, California, 91325, United States

Location

Yafa Minazad

Pasadena, California, 91105, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

Collaborative Neuroscience Network

Torrance, California, 90502, United States

Location

Neurosearch II Inc

Ventura, California, 93003, United States

Location

Neurosciences Clinic - University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Denver Health

Denver, Colorado, 80204, United States

Location

Associated Nuerologists, PC

Danbury, Connecticut, 06810, United States

Location

JEM Research, LLC

Atlantis, Florida, 33462, United States

Location

Bradenton Clinical Research

Bradenton, Florida, 34205, United States

Location

Miami Research Inc.

Coral Gables, Florida, 33134, United States

Location

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, 32561, United States

Location

Palm Springs Research Institute

Hialeah, Florida, 33012, United States

Location

Infinity Clinical Research, LLC

Hollywood, Florida, 33021, United States

Location

Neurology Associates

Maitland, Florida, 32751, United States

Location

San Marcus Research Clinic

Miami, Florida, 33015, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Neuroscience Consultants

Miami, Florida, 33176, United States

Location

Pediatric Neurology, PA

Orlando, Florida, 32819, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Bay Neurological Institute

Panama City, Florida, 32405, United States

Location

Medsol Clinical Research Center

Port Charlotte, Florida, 33952, United States

Location

Pediatric Epilepsy & Neurology Specialists, PA

Tampa, Florida, 33609, United States

Location

Palm Beach Clinical Research Network, LLC

Wellington, Florida, 33414, United States

Location

PANDA Neurology and Atlanta Heachache Specialists

Atlanta, Georgia, 30328, United States

Location

Harbin Clinic

Rome, Georgia, 30165, United States

Location

Consultants in Epilepsy and Nuerology

Boise, Idaho, 83702, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

J.W.M. Neurology P.C.

Indianapolis, Indiana, 46237, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Bluegrass Epilepsy Research, LLC

Lexington, Kentucky, 40504, United States

Location

ECommunity Research LLC

Hammond, Louisiana, 70403, United States

Location

MMP Neuroloy

Scarborough, Maine, 04704, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Wayne State University/Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Minneappolis Clinic of Neurology

Golden Valley, Minnesota, 55422, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Comprehensive Epilepsy Care Center for Children and Adults

Chesterfield, Missouri, 63017, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

University Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

UMDNJ DOC 8th Floor 8100

Newark, New Jersey, 07103, United States

Location

Five Towns Neuroscience Research

Cedarhurst, New York, 11516, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

PMG Research of Hickory, LLC

Hickory, North Carolina, 28602, United States

Location

Department of Neurology

Winston-Salem, North Carolina, 27517, United States

Location

Ohio Clinical Research Partners, LLC

Canton, Ohio, 44718, United States

Location

The University of Toledo Health Science Campus

Toledo, Ohio, 43614, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Tulsa Clinical Research LLC

Tulsa, Oklahoma, 74104, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University School of Medicine, Dept of Neurology

Philadelphia, Pennsylvania, 19140, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15201, United States

Location

Gus Stratton / Neurology

Cranston, Rhode Island, 02920, United States

Location

VU Department of Neurology

Nashville, Tennessee, 37232, United States

Location

Neurology Associates of Arlington, P.A.

Arlington, Texas, 76107, United States

Location

Edwin A Green, Jr., MD

Brownwood, Texas, 76801, United States

Location

Texas Neurology, PA

Dallas, Texas, 75214, United States

Location

Neurological Clinic of Texas, P.A.

Dallas, Texas, 75230, United States

Location

UT Health Science Center at Houston/ Dept of Neurology

Houston, Texas, 77030, United States

Location

MD

Houston, Texas, 77063, United States

Location

Neurology Associates of Arlington, P.A.

Mansfield, Texas, 76063, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

Road Runner Research

San Antonio, Texas, 78258, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

University of Utah Department of Neurology

Salt Lake City, Utah, 84132, United States

Location

Neurological Associates of Washington

Bellevue, Washington, 98004, United States

Location

Rainier Clinical Research Center Inc.

Renton, Washington, 98057, United States

Location

Pacific Medical Centers

Seattle, Washington, 98144, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Regional Epilepsy Center

Milwaukee, Wisconsin, 53215, United States

Location

Multiprofile Hospital for Active Treatment "Pulse," AD, Town of Blagoegrad

Blagoevgrad, 2700, Bulgaria

Location

Univesity Multiprofile Hospital for Active Treatment "Dr. George Stranski," EAD, town of Pleven

Pleven, 5800, Bulgaria

Location

Second Multiprofile Hospital for Active Treatment

Sofia, 1202, Bulgaria

Location

Diagnostic and Consultative Center "Equita" EOOD, town of Varna Neurology office

Varna, 9000, Bulgaria

Location

London Health Sciences Centre, University Campus

London, Ontario, N6A 5A5, Canada

Location

Neuro-Epilepsy Clinic/ Neuro Rive-Sud

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Policlinic Chocen, Private Neurology

Smetanova Lhota, Chocen, 56501, Czechia

Location

Cerebrovaskularni poradna s.r.o

Třebovice, Ostrava, 722 00, Czechia

Location

CTC Rychnov nad Kneznou

Rychnov nad Kněžnou, Praugue, 516 01, Czechia

Location

Evzen Nespor

Prague, Strasnice, Czechia

Location

Poradna pro epilepsie

Koty, Zlín, 760 01, Czechia

Location

Neurologicka ordinance

Prague, 160 00, Czechia

Location

Clinic of Neurology, Clinical Center of Serbia

Belgrade, 11 000, Serbia

Location

Institute of Mental Health, Department of epilepsy and clinical neurophysiology

Belgrade, 11 000, Serbia

Location

Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after l.l. Mechnikov" Regional Center of psychosomatic disorders, Psychoneurology department for patients with psychosomatic disorders and borderline conditions

Dnipropetrovsk, 49005, Ukraine

Location

Communal Medical and Preventive Treatment Institution "Regional Clinical Psychiatric Hospital" Donetsk National Medical University

Donetsk, 83008, Ukraine

Location

State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology

Kharkiv, 61018, Ukraine

Location

State Institution "Institute of neurology, psychiatry, and narcology of AMS of Ukraine" Department of cerebrovascular patology

Kharkiv, 61068, Ukraine

Location

State Institution "Institute of the Health Care of Children and Adolescents of Academy of Medical Sciences of Ukraine Dept of Psych

Kharkiv, 61153, Ukraine

Location

State Institution Railway Clinical Hospital #1 of Kiev Railway Station of DTGO South Western Railroad Psycho-neurological Department

Kiev, 01030, Ukraine

Location

Communal Institution "Lviv Regional Clinical Psych Hospital"

Lviv, 79021, Ukraine

Location

Communal Institution "Odessa Regional Clinical Psych Hospital #1" Department of Day Care

Odesa, 65006, Ukraine

Location

Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev

Poltava, 36006, Ukraine

Location

Crimean Republican Institution "Clinical Psychiatric Hospital #1"

Simferopol, 95006, Ukraine

Location

Communal Institution "Vinnystsia Regional Psycho-Neurological Hospital named after O.I. Yuschenko, Vinnytsia National Medical University named after M.I. Pirogov, Dispensary department, Department of Psychiatry and Addictology

Vinnytsia, 21005, Ukraine

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltrialsdisclosure@sunovion.com

1-866-503-6351

Study Officials

• CNS Medical Director

  Sunovion Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 29, 2009
• Study Start: August 1, 2009
• Primary Completion: April 15, 2017
• Study Completion: April 15, 2017
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-07

Locations

CA (3); SE (2); CZ (6); BU (4); US (96); UA (11)