Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

NCT ID: NCT00866775

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-05-31

Brief Summary

This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.

Detailed Description

This is an 18-week, double-blind, randomized, historical control, multicenter study with gradual conversion to monotherapy in subjects with partial onset seizures who are not well controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week period for titration of study drug, 6-week period for taper or conversion off AEDs, and a 10-week monotherapy period. Subjects not entering an optional open-label extension study will enter a 1-week period to taper off study drug followed by an end of study visit (week 19). 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 With Simple or Complex Partial Onset Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Eslicarbazepine 1600 mg QD

Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg QD (Day 0) to 1200 mg QD (Week 1) to 1600 mg QD (Weeks 2-18)

Subjects may continue in an open-label extension study with a starting dose of 1600 mg QD, or taper off study drug at the completion of this study The treatment period for subjects entering the open label extension study is up to 9 study visits over 18 weeks. The treatment period for subjects not entering the open-label extension study is up to 10 study visits over 19 weeks.

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

1600 mg QD

Eslicarbazepine 1200 mg QD

Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg QD (Day 0) to 800 mg QD (week 1) to 1200 mg QD (weeks 2-18)

Subjects may continue in an open-label extension study with a starting dose of 1600 mg QD, or taper off study drug at the completion of this study The treatment period for subjects entering the open label extension study is up to 9 study visits over 18 weeks. The treatment period for subjects not entering the open-label extension study is up to 10 study visits over 19 weeks.

Group Type: EXPERIMENTAL

Eslicarbazepine acetate

Intervention Type: DRUG

1200 mg QD

Interventions

Eslicarbazepine acetate

1600 mg QD

Intervention Type: DRUG

Eslicarbazepine acetate

1200 mg QD

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of partial epilepsy as defined in the Classification of Seizures of the International League Against Epilepsy (ILAE) (simple partial seizures with observable motor component, or complex, with or without secondary generalization) a. Medical history of seizures; b. Absence of confounding factors (pseudoseizures, syncope); c. Documented EEG recording (done within 5 years prior to screening) consistent with focal onset epilepsy.
• Documented CT or MRI scan conducted within 10 years prior to screening, showing the absence of a progressive structural abnormality (eg, tumor). Mesial temporal sclerosis is acceptable.
• ≥4 partial onset seizures during the 8 weeks prior screening with no 28-day seizure free period.
• Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening.
• Subjects must have the ability to comprehend the informed consent form and be willing to provide informed consent. For subjects who are unable to comprehend the written consent, a witness/caregiver who is able to describe and provide an understanding of the informed consent to the subject must sign the consent form on behalf of the subject.
• Subjects 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. Subjects of Asian ancestry are required to give written informed consent for genotyping. All subjects must sign a HIPAA Form. All females of child bearing potential must also sign the "Women of Childbearing Potential" Addendum.
• A female subject is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal); b. Child-bearing potential (all females ≤65 years of age), has a negative pregnancy test at screening and agrees to satisfy contraception requirements.

Exclusion Criteria

• Subjects with only simple partial seizures without a motor component.
• Presence of generalized seizure syndromes (eg, juvenile myoclonic epilepsy or Lennox-Gastaut syndrome).
• History of pseudo-seizures.
• Current seizures related to an acute medical illness.
• Seizures secondary to metabolic, toxic or infectious disorder or drug abuse.
• Status epilepticus within 2 years prior to screening.
• Seizures only occurring in a cluster pattern.
• Subjects taking 2 of the following sodium channel blocking AEDs: phenytoin, carbamazepine, oxcarbazepine, or lamotrigine.
• Subjects taking 2 AEDs with both being in the upper dose range (defined as approximately two-thirds of the defined daily dose).
• Subjects taking more than 2 AEDs.
• Subjects with progressive structural central nervous system lesion or progressive encephalopathy.
• Subjects who have been on benzodiazepines, phenobarbital, or primidone on a regular basis within 3 months prior to screening.
• Subjects taking antipsychotics, tricyclic antidepressants, anxiolytics, sedative hypnotics including non-benzodiazepines, central opioid agonists/antagonists, monoamine oxidase inhibitors (MAOIs) within at least 5 half lives (or for at least 2 weeks whichever is longer) prior to randomization.
• Subjects presently on felbamate or vigabatrin
• Female subjects who are currently breastfeeding or intending to breastfeed during study period.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CNS Medical Director

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Norwood Neurology

Birmingham, Alabama, United States

Greystone Neurology Center

Birmingham, Alabama, United States

USA Neurology

Mobile, Alabama, United States

Neurology Clinic, P.C.

Northport, Alabama, United States

Clinical Research Consortium

Phoenix, Arizona, United States

Clinical Research Consortium - Arizona

Phoenix, Arizona, United States

Xenoscience Inc.

Phoenix, Arizona, United States

Arizona Neurological Institute

Sun City, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

K & S Professional Research Services

Little Rock, Arkansas, United States

Sutter East Bay Medical Foundation

Berkley, California, United States

Synergy Escondido

Escondido, California, United States

Collaborative Neuroscience Network

Garden Grove, California, United States

Faculty of Physicians & Surgeons of Loma Linda University

Loma Linda, California, United States

Loma Linda University

Loma Linda, California, United States

American Institute of Research

Los Gatos, California, United States

Northridge Neurological Center

Northridge, California, United States

Yafa Minazad, DO

Pasadena, California, United States

Neurological Research Institute

Santa Monica, California, United States

American Institute of Research

Whittier, California, United States

Anschutz Outpatient Pavilion

Aurora, Colorado, United States

Denver Health Medical Center

Denver, Colorado, United States

Associated Neurologists, PC

Danbury, Connecticut, United States

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Miami Clinical Research

Coral Gables, Florida, United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States

Infiniti Clinical Research, LLC

Hollywood, Florida, United States

University of Florida Health Science Center

Jacksonville, Florida, United States

Neurology Associates, PA

Maitland, Florida, United States

MIMA Century Research Associates

Melbourne, Florida, United States

San Marcus Research Clinic

Miami, Florida, United States

Neurosciences Consultants, LLC

Miami, Florida, United States

Neurological Services Orlando

Orlando, Florida, United States

Pediatric Neurolog, PA

Orlando, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Medsol Clinical Research Center

Port Charlotte, Florida, United States

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Pediatric Epilepsy & Neurology Specialists, PA

Tampa, Florida, United States

Florida Comprehensive Epilepsy and Seizure Disorder Center

Tampa, Florida, United States

Vero Neurology

Vero Beach, Florida, United States

Palm Beach Clinical Research Network LLC

Wellington, Florida, United States

Peachtree Neurological Clinic

Atlanta, Georgia, United States

Emory University Department of Neurology

Atlanta, Georgia, United States

PANDA Neurology and Atlanta Headache Specialists

Atlanta, Georgia, United States

Harbin Clinic

Rome, Georgia, United States

GA Neurology and Sleep Medicine Associates

Suwanee, Georgia, United States

Consultants in Epilepsy and Neurology, PLLC.

Boise, Idaho, United States

Rush University

Chicago, Illinois, United States

UCMC

Chicago, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Southern Illinois University

Springfield, Illinois, United States

Central DuPage Hospital

Winfield, Illinois, United States

McFarland Clinic, PC

Ames, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Bluegrass Epilepsy Research LLC

Lexington, Kentucky, United States

North Oaks Neurology

Hammond, Louisiana, United States

MMP Neurology

Scarborough, Maine, United States

John Hopkins University

Baltimore, Maryland, United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Massachusetts General Hospital Epilepsy Service - WACC

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Precise Research Centers

Flowood, Mississippi, United States

The Comprehensive Epilepsy Care Center for Children and Adults

Chesterfield, Missouri, United States

PsychCare Consultants Research

St Louis, Missouri, United States

Cooper University Health System

Camden, New Jersey, United States

Cooper University Health System

Cherry Hill, New Jersey, United States

NJ Neuroscience Center

Edison, New Jersey, United States

Institute of Neurology and Neurosurgery at St. Bamabas, Suite 101

Livingston, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, United States

St. Joseph's Regional Medical Center

Paterson, New Jersey, United States

Five Towns Neuroscience Research

Cedarhurst, New York, United States

Winthrop University Hospital

Mineola, New York, United States

Beth Israel Medical Center

New York, New York, United States

Clinilabs Inc.

New York, New York, United States

University of Rochester

Rochester, New York, United States

The Neurology Institute

Charlotte, North Carolina, United States

PMG Research of Hickory, LLC

Hickory, North Carolina, United States

Wake Forest University

Winstom-Salem, North Carolina, United States

Northern Ohio Neurosciences

Bellevue, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

5929 N. May Ave.

Oklahoma City, Oklahoma, United States

Providence Medical Group

Medford, Oregon, United States

Children's Hospital Philadelphia

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburg of UPMC

Pittsburgh, Pennsylvania, United States

Gus Stratton / Neurology

Cranston, Rhode Island, United States

Mid-South Physcians Group

Germantown, Tennessee, United States

Access Clinical Trials

Nashville, Tennessee, United States

VU Department of Neurology

Nashville, Tennessee, United States

Neurology Associates of Arlington, PA

Arlington, Texas, United States

Texas Neurology, PA

Dallas, Texas, United States

Neurological Clinic of Texas P.A.

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

UT Health Science Center at Houston

Houston, Texas, United States

Todd Swick, MD, PA

Houston, Texas, United States

Neurology Associates of Arlington, PA

Mansfield, Texas, United States

Scott and White Memorial Hospital

Temple, Texas, United States

Sentara Neurology Specialists

Norfolk, Virginia, United States

Neurological Associates of Washington/Clinical Trials of America Inc.

Bellevue, Washington, United States

Rainier Clinical Research Center, Inc.

Renton, Washington, United States

Pacific Medical Centers

Seattle, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

London Health Sciences Center

London, Ontario, Canada

Neuro-Epilepsy Clinic

Greenfield Park, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

United States; Canada

References

Sperling MR, Harvey J, Grinnell T, Cheng H, Blum D; 045 Study Team. Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a randomized historical-control phase III study based in North America. Epilepsia. 2015 Apr;56(4):546-55. doi: 10.1111/epi.12934. Epub 2015 Feb 16.

Reference Type: BACKGROUND

PMID: 25689448 (View on PubMed)

Other Identifiers

093-045

Identifier Type: -

Identifier Source: org_study_id