A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures
- Conditions
- Epilepsy With Partial On-set Seizures
- Interventions
- Registration Number
- NCT03116828
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
A study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures
- Detailed Description
This is a 31-week, multicenter, 2-arm, prospective, open-label, non-randomized, Phase 4 study of eslicarbazepine acetate (ESL) as adjunctive therapy in adult subjects with a diagnosis of epilepsy with POS. Two groups of ESL-naïve subjects will be evaluated. The groups are defined as follows:
* Arm 1 (ESL as first add-on): This group will include subjects who have been maintained on a regimen consisting of a stable dose of LEV or LTG for at least 1 month (28 days) prior to screening and who have not used any adjunctive treatment.
* Arm 2 (ESL as later add-on): This group will include subjects who have been maintained on a regimen consisting of a stable dose of 1-2 AEDs (excluding oxcarbazepine \[OXC\]) for at least 1 month (28 days) prior to screening and who have used adjunctive treatment in the past.
The Arm 1 subjects will allow an assessment of the efficacy and safety of ESL in subjects who are early in the course of their disease and being treated with one of the most common first line AEDs.
The subjects in Arm 2 are similar to the subject population in the ESL Phase 3 adjunctive epilepsy studies, treatment-resistant subjects who are later in the course of their disease. The inclusion of these subjects in the present study will provide an assessment of the efficacy and safety of ESL as a later adjunctive therapy in a real world clinical setting.
In addition, this study will provide data from both Arm 1 and Arm 2 for several behavioral, mood-related, and QOL-related assessments that were not evaluated in the ESL Phase 3 adjunctive epilepsy program.
The study will consist of a Screening Phase of 1 to 2 weeks, followed by a 2-week Titration Phase, a 24-week Maintenance Phase, and a Safety Follow-up/Taper Phase of 4 weeks. The last visit in the Maintenance Phase (Visit 9) is considered the End of Study (EOS) visit
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
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Male or female subjects ≥ 18 years of age.
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Subject is willing and able to sign informed consent.
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Subject has a documented diagnosis of epilepsy with simple POS with a motor component or complex POS with or without secondarily generalized seizures as defined in the Classification of Seizures of the International League Against Epilepsy
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Subject has a documented electroencephalogram within 10 years prior to screening.
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Subject has had at least 3 POS during previous six months.
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Subject has had a sufficient number of seizures at time of enrollment to justify adjunctive therapy, as determined by the Investigator.
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Subjects are required to be ESL-naïve AND
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Maintained on a stable LEV or LTG regimen for at least 1 month (28 days) prior to screening with no history of adjunctive treatment (for Arm 1, ESL as first add-on).
OR
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Maintained on a stable dose of 1-2 AEDs (excluding OXC) for at least 1 month (28 days) prior to screening and who have had prior adjunctive treatment (for Arm 2, ESL as later add-on).
-
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If the subject is treated with any stimulation device for epilepsy Vagal Nerve Stimulation (VNS), Responsive Neurostimulator (RNS), or similar, the device must have been implanted at least 6 months before screening and the device parameters must be documented as stable for at least 1 month prior to screening. (Note: These devices will not be counted as concomitant AED).
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Except for epilepsy, subject is judged to be in general good health based on medical history, physical examination findings, and clinical laboratory
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Subjects with a prior exposure to ESL.
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Subjects currently being treated with OXC.
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Subject with a history of allergic reaction to OXC or CBZ, or a history of serious allergic reaction (Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms or similar) to any AED, or a history of serious allergic reactions to other medications.
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Subjects who have taken warfarin, felbamate, vigabatrin, or perampanel, (unless at stable dose with safety testing for ≥ 1 year) within a 4-week period prior to screening.
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Subjects taking ezogabine
.
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Subject has taken any medication prohibited for this protocol within 4 weeks prior to Screening
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Subjects using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as an AED
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Seizure disorder characterized primarily by simple POS without motor signs.
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Subject has a history of primarily generalized seizures (eg, myoclonic, absence, tonic).
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Subject has a history of status epilepticus or cluster seizures (ie, 3 or more seizures within 30 minutes) within the 3 months prior to screening.
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Subject has had seizures of psychogenic origin or purely subjective seizures within the last 2 years.
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Subject has had seizures too close to count accurately.
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Subject has a known progressive structural central nervous system (CNS) lesion, progressive encephalopathy or any other condition that may result in epilepsy secondary to a cerebral abnormality.
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Subject whose current seizures are related to an acute medical illness or other non-epileptic origin.
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Subjects of Asian ancestry will be excluded if they are carriers of HLA-B*1502. Either:
- Subject must give written informed consent for genotyping, and test negative. OR
- Subjects must provide documentation of prior testing confirming non-carrier status.
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Subject has a major medical illness other than epilepsy that would prevent safe participation in this study, at the discretion of the Investigator, including (but not limited to) cardiac disease, thyroid disease, hepatic or renal impairment, endocrine or metabolic disease, gastrointestinal disease, or hematologic disease. Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. If the effect of the condition in regard to the risk to the subject or to the study results is unclear, the Medical Monitor should be consulted.
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Subjects with clinically relevant laboratory abnormalities at screening (eg, sodium < 130 mEq/L, alanine transaminase (ALT) or aspartate transaminase (AST) > 2.0 times the upper limit of the normal, white blood cell [WBC] count < 3,000 cells/mm3, estimated creatinine clearance < 50 mL/min, or has values for thyroid testing (free triiodothyronine (T3), free thyroxine (T4), thyroid stimulating hormone [TSH]) indicating the presence of significant thyroid dysfunction.
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Subject has a history or presence of abnormal electrocardiogram (ECG), which in the Investigator's opinion is clinically significant or QT interval corrected for heart rate using the Fridericia method (QTcF) of ≥ 450 msec per screening ECG.
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Subject has second or third-degree atrioventricular block that is not corrected with a pacemaker.
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Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th edition text revision defined criteria for major depressive episode within the last 6 months. Subjects with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of a single antidepressant are acceptable.
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Subject has an active suicidal plan or intent (in the Investigator's opinion) in the past 4 weeks prior to screening.
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Subject has a history of suicide attempt in the last 2 years prior to screening.
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Subject has other major psychiatric disorders.
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Subjects who are not able to complete the diary in the Investigator's opinion.
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Subject has a history of alcohol or substance abuse within 2 years prior to screening for study participation, or subjects currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner, which, in the opinion of the Investigator, indicates abuse.
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Subject tests positive for drugs of abuse at screening. Note: Subjects with a positive drug screen for marijuana, amphetamines, opiates, or benzodiazepines, who have a documented prescription for a medical condition and are on a stable dose of this prescribed medication for at least 4 weeks prior to screening, may be eligible to participate in the study upon approval from the Medical Monitor.
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Subject is pregnant, currently nursing, or intends to become pregnant during the study period or within 30 days of the last dose of study drug.
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Subject has participated in any investigational study within 30 days prior to screening, as documented in subject's medical history.
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Subject is a clinical or investigational site staff member or relative of a staff member.
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Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description eslicarbazepine acetate (arm 1) Eslicarbazepine Acetate eslicarbazepine acetate (as first add-on)mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites) eslicarbazepine acetate (arm 2) Eslicarbazepine Acetate eslicarbazepine acetate (as later add-on)
- Primary Outcome Measures
Name Time Method The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase From the date of the first dose of the study drug until the completion of 24 weeks Maintenance Phase Phase 4 study of eslicarbazepine acetate (ESL) as adjunctive therapy in adult subjects with a diagnosis of epilepsy with Partial-onset seizures (POS). Two groups of ESL-naïve subjects will be evaluated
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (55)
Temple University Lewis Katz School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Aston Ambulatory Care Center
🇺🇸Dallas, Texas, United States
Northwestern Medical Group, Deparment of Neurology
🇺🇸Chicago, Illinois, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Vanderbilt Epilepsy Clinic
🇺🇸Nashville, Tennessee, United States
University of Texas Health Science Center at San Antonio Medical Arts and Research Center
🇺🇸San Antonio, Texas, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Clinical Research Center of NJ (CRCNJ)
🇺🇸Voorhees, New Jersey, United States
University of South Alabaa Neurology Department
🇺🇸Mobile, Alabama, United States
Altman Clinical and Translational Research Institute
🇺🇸La Jolla, California, United States
Banner University Medical Center Phoenix=Neuroscience Institute
🇺🇸Phoenix, Arizona, United States
Blue Sky Neurology, a Division of Carepoint PC
🇺🇸Englewood, Colorado, United States
George Washington Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
University of Connecticut School of Mwdicine -UCONN Health
🇺🇸Farmington, Connecticut, United States
Neurology Associates PA
🇺🇸Maitland, Florida, United States
The Neurology Research Group, LLC
🇺🇸Miami, Florida, United States
Laszlo J. Mate, MD, PA
🇺🇸North Palm Beach, Florida, United States
Medsol Clinical Research Center
🇺🇸Port Charlotte, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Minneapolis Clinic of Neurology
🇺🇸Golden Valley, Minnesota, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
Vero Beach Neurology And Reasearch Institue/The MS Center of Vero Beach
🇺🇸Vero Beach, Florida, United States
Balijeet Shethi, MD
🇺🇸Waldorf, Maryland, United States
Georgia Neurology and Sleep Medicine Associates
🇺🇸Suwanee, Georgia, United States
Conslutants in Epilepsy & Neurology, PLLC
🇺🇸Boise, Idaho, United States
Associates in Neurology, PSC
🇺🇸Lexington, Kentucky, United States
Minnesota Epilepsy Group, PA
🇺🇸Saint Paul, Minnesota, United States
Wayne State University/Detroit Medical Center
🇺🇸Detroit, Michigan, United States
JFK Neuroscience Institute, JFK Medical Center
🇺🇸Edison, New Jersey, United States
Austin Epilepsy Care Center
🇺🇸Austin, Texas, United States
NYU Winthrop Hospital, Clinical Trials Center
🇺🇸Mineola, New York, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
The Neurological Institute, PA
🇺🇸Charlotte, North Carolina, United States
Providence Medical Group-Medford Neurology
🇺🇸Medford, Oregon, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
SSM Health Dean Medical Group
🇺🇸Madison, Wisconsin, United States
Londo Health Sciences Centre, University Hospital
🇨🇦London, Ontario, Canada
University of Kentucky Hospital, Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Boca Raton Regional Hospital, Marcus Neuroscience Institute
🇺🇸Boca Raton, Florida, United States
Rancho Research Institute, Inc.
🇺🇸Downey, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
University of California-Irvine
🇺🇸Orange, California, United States
Infinity Clinical Research, LLC
🇺🇸Hollywood, Florida, United States
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Clinique D'Épilepsie Neuro Rive-Sud
🇨🇦Greenfield Park, Quebec, Canada
Alleghany General Hospital (Allegheny Neurological Association)
🇺🇸Pittsburgh, Pennsylvania, United States
Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States
UNC Inverstigal Drug Services
🇺🇸Chapel Hill, North Carolina, United States
Neurological Services of Orlando, PA
🇺🇸Orlando, Florida, United States
Pedicatric Neurology, PA
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Wake Forest Baptist Health Sciences, Department of Neurology
🇺🇸Winston-Salem, North Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States