Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic

NCT ID: NCT01091662

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-11-30

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 titration period, 6-week taper or conversion period, and a 10-week monotherapy period. 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

Study Design

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

Study Groups

eslicarbazepine acetate 1600 mg

Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg QD(Day 0) to 1200 mg once a day(Week 2) to 1600 mg QD (Weeks 3-18) and may taper down from 1600 mg to 800 mg QD 3 days after the Week 18 visit.

Group Type: EXPERIMENTAL

Eslicarbazepine acetate 1600 mg

Intervention Type: DRUG

1600 mg once per day

eslicarbazepine acetate 1200 mg

Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg QD (Day0) to 800 mg QDweek2) to 1200 mg QD(weeks 3-18) and may taper down from 1200 mg to 600 mg QD 3 days after the Week 18 visit.

Subjects may continue in an open-label extension study with a starting dose of 1200 mg QD, or taper off their previous antiepileptic drugs during weeks 2-8.

Group Type: EXPERIMENTAL

Eslicarbazepine acetate 1200 mg

Intervention Type: DRUG

1200 once per day

Interventions

Eslicarbazepine acetate 1600 mg

1600 mg once per day

Intervention Type: DRUG

Eslicarbazepine acetate 1200 mg

1200 once per day

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)

• Medical history of seizures;
• Absence of confounding factors (pseudoseizures, syncope);
• 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 structural abnormality (eg, tumor or malformation)
• ≥ 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:

• Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal);
• 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

• 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 Dirctor

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

University of Arizona Health Sciences Center

Tucson, Arizona, United States

Arkansas Neurology

Conway, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kern County Neurological Medical Group, INC.

Bakersfield, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

West Los Angeles VA Medical Center

Los Angeles, California, United States

Neurosearch II Inc.

Ventura, California, United States

Specialty Nuerology, PC

Englewood, Colorado, United States

Palm Springs Research Institute, Inc

Hialeah, Florida, United States

Miami Children's Hospital

Miami, Florida, United States

Pharma Care Research LLC

Miami, Florida, United States

Bay Neurological Institute

Panama City, Florida, United States

Loveland Scientific Resources Inc.

Venice, Florida, United States

Josephson Wallack Munshower Neurology PC

Indianapolis, Indiana, United States

University of Kentucky Department of Neurology

Lexington, Kentucky, United States

Louisiana State University Health Science Center - Shreveport

Shreveport, Louisiana, United States

The Sandra and Malcom Berman Brain & Spine Institute

Baltimore, Maryland, United States

Lahey Clinic

Burlington, Massachusetts, United States

Wayne State University/Detroit Medical Center

Detroit, Michigan, United States

Minneappolis Clinic of Neurology

Golden Valley, Minnesota, United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, United States

UMDNJ DOC 8th Floor 8100

Newark, New Jersey, United States

Global Medical Institutes, LLC

Princeton, New Jersey, United States

Shore Neurology, PA

Toms River, New Jersey, United States

Dent Neurologic Institute

Orchard Park, New York, United States

SUNY Upstate Medical University Department of Neurology

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

East Carolina Neurology

Greenville, North Carolina, United States

Ohio Clinical Research Partners, LLC

Canton, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Tulsa Clinical Research LLC

Tulsa, Oklahoma, United States

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

Community Clinical Research Inc.

Austin, Texas, United States

Brownwood Regional Medical Center

Brownwood, Texas, United States

MD

Dallas, Texas, United States

Vital Clinical Research

DeSoto, Texas, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Regional Epilepsy Center

Milwaukee, Wisconsin, United States

Multirprofile Hospital for Active Treatment "Pulse," AD, town of Blagoevgrad

Blagoevgrad, Bulgaria, Bulgaria

Second Multiprofile Hospital for Active Treatment - Sofia, AD, city of Sofia Neurology Department

Sofia, Bulgaria, Bulgaria

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski," EAD, town of Pleven

Pleven, Pleven, Bulgaria

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

Varna, Varna, Bulgaria

Policlinic Chocen, private neurology

Smetanova, Chocen, Czechia

Prague, Pocernicka, Czechia

Neurologicka ordinance

Kolejni, Prague, Czechia

CTC Rycnov nad Kneznou

Rychnov nad Kněžnou, Praugue, Czechia

Cerebrovaskularni poradna s.r.o.

Ostrava, Tiebovice, Czechia

Poradna pro epilepsie

Koterova, Zin, Czechia

Clinic of Neurology, Clinical Center of Serbia

Belgrade, Belgrade, Serbia

Institute of Mental Health, Department of epilepsy and clinical neurophysiology

Palmoticeva, Belgrade, Serbia

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 condtions

Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine

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

Donetsk, Donetsk Oblast, Ukraine

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

Kharkiv, Kharkivs’ka Oblast’, Ukraine

State Treatment and Prevention Institution

Kharkiv, Kharkov, Ukraine

State Institution "Institute of the Health Care of Children & Adolescents of Academy of Medical Sciences of Ukraine" Dept of Psychiatry

Kharkiv, Kharkov, Ukraine

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

Kiev, Kyiv City, Ukraine

Communal Institution "Lviv Regional Clinical Psychiatric Hospital" Department #20, Lviv National Medical University, named after Danylo

Lviv, Lviv Oblast, Ukraine

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

Odesa, Odesa Oblast, Ukraine

Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev

Poltava, Poltava Oblast, Ukraine

Crimean Republic Institution "Clinical Psychiatric Hospital #1"

Simferopol, Simferopol, Ukraine

Communal Institution "Vinnytsia 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, Vinnytsia Oblast, Ukraine

Countries

United States; Bulgaria; Czechia; Serbia; Ukraine

References

Jacobson MP, Pazdera L, Bhatia P, Grinnell T, Cheng H, Blum D; study 046 team. Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a historical-control phase III study. BMC Neurol. 2015 Mar 28;15:46. doi: 10.1186/s12883-015-0305-5.

Reference Type: BACKGROUND

PMID: 25880756 (View on PubMed)

Other Identifiers

093-046

Identifier Type: -

Identifier Source: org_study_id