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

Completed · Phase 3

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01091662

Run by

Sumitomo Pharma America, Inc.

People needed

172

Starts

2010-06-01

Expected to finish

2012-11-01

Last updated by the study team

2016-10-24

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Psychiatric exclusion criteria
• Medical exclusion criteria: known renal insufficiency (estimated creatinine clearance [CrCL]) <60 mL/min based on serum creatinine using the Cockcroft-Gault formula
• Clinical and laboratory exclusion criteria: Subjects of Asian ancestry who tests positive for the presence of the HLA-B*1502 allele
• 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

Where it is running

• 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
• University of Arizona Health Sciences Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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