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Epilepsy With Partial On-set SeizuresPhase 4NCT03116828

A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

A Phase 4 study testing Eslicarbazepine acetate in people with Epilepsy With Partial On-set Seizures, run by Sumitomo Pharma America, Inc. at 55 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Epilepsy With Partial On-set Seizures
What is being tested?
Eslicarbazepine acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
55 sitesin 2 countries
Study dates
7 Jul 2017to 6 Jun 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects ≥ 18 years of age.
  • Subject is willing and able to sign informed consent.
  • 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
  • Subject has a documented electroencephalogram within 10 years prior to screening.
  • Subject has had at least 3 POS during previous six months.
  • Subject has had a sufficient number of seizures at time of enrollment to justify adjunctive therapy, as determined by the Investigator.
Show all 12Show fewer
  • Subjects are required to be ESL-naïve AND
  • 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
  • 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).
  • 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).
  • Except for epilepsy, subject is judged to be in general good health based on medical history, physical examination findings, and clinical laboratory

Who cannot join

  • Subjects with a prior exposure to ESL.
  • Subjects currently being treated with OXC.
  • 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.
  • 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.
  • Subjects taking ezogabine
  • .
Show all 33Show fewer
  • Subject has taken any medication prohibited for this protocol within 4 weeks prior to Screening
  • Subjects using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as an AED
  • Seizure disorder characterized primarily by simple POS without motor signs.
  • Subject has a history of primarily generalized seizures (eg, myoclonic, absence, tonic).
  • 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.
  • Subject has had seizures of psychogenic origin or purely subjective seizures within the last 2 years.
  • Subject has had seizures too close to count accurately.
  • 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.
  • Subject whose current seizures are related to an acute medical illness or other non-epileptic origin.
  • 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.
  • 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.
  • 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.
  • 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.
  • Subject has second or third-degree atrioventricular block that is not corrected with a pacemaker.
  • 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.
  • Subject has an active suicidal plan or intent (in the Investigator's opinion) in the past 4 weeks prior to screening.
  • Subject has a history of suicide attempt in the last 2 years prior to screening.
  • Subject has other major psychiatric disorders.
  • Subjects who are not able to complete the diary in the Investigator's opinion.
  • 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.
  • 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.
  • 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.
  • Subject has participated in any investigational study within 30 days prior to screening, as documented in subject's medical history.
  • Subject is a clinical or investigational site staff member or relative of a staff member.
  • Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol.

Trial locations and contacts

55 sites in 2 countries.

55 sites in 2 countries

United States53 sites

  • Austin Epilepsy Care Center

    Austin, Texas, 78758

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817

  • Boca Raton Regional Hospital, Marcus Neuroscience Institute

    Boca Raton, Florida, 33486

  • Conslutants in Epilepsy & Neurology, PLLC

    Boise, Idaho, 83702

  • UNC Inverstigal Drug Services

    Chapel Hill, North Carolina, 27514

  • The Neurological Institute, PA

    Charlotte, North Carolina, 28204

  • Northwestern Medical Group, Deparment of Neurology

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Aston Ambulatory Care Center

    Dallas, Texas, 75390

  • Wayne State University/Detroit Medical Center

    Detroit, Michigan, 48201

  • Rancho Research Institute, Inc.

    Downey, California, 90242

  • JFK Neuroscience Institute, JFK Medical Center

    Edison, New Jersey, 08820

  • Blue Sky Neurology, a Division of Carepoint PC

    Englewood, Colorado, 80113

  • University of Connecticut School of Mwdicine -UCONN Health

    Farmington, Connecticut, 06030

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33021

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Altman Clinical and Translational Research Institute

    La Jolla, California, 92037

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Associates in Neurology, PSC

    Lexington, Kentucky, 40513

  • University of Kentucky Hospital, Chandler Medical Center

    Lexington, Kentucky, 40536

  • SSM Health Dean Medical Group

    Madison, Wisconsin, 53715

  • Neurology Associates PA

    Maitland, Florida, 32751

  • Providence Medical Group-Medford Neurology

    Medford, Oregon, 97504

  • The Neurology Research Group, LLC

    Miami, Florida, 33176

  • NYU Winthrop Hospital, Clinical Trials Center

    Mineola, New York, 11501

  • University of South Alabaa Neurology Department

    Mobile, Alabama, 36604

  • Vanderbilt Epilepsy Clinic

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Laszlo J. Mate, MD, PA

    North Palm Beach, Florida, 33408

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • University of California-Irvine

    Orange, California, 92868

  • Neurological Services of Orlando, PA

    Orlando, Florida, 32806

  • Pedicatric Neurology, PA

    Orlando, Florida, 32819

  • Drexel University

    Philadelphia, Pennsylvania, 19107

  • Temple University Lewis Katz School of Medicine

    Philadelphia, Pennsylvania, 19140

  • Banner University Medical Center Phoenix=Neuroscience Institute

    Phoenix, Arizona, 85006

  • Alleghany General Hospital (Allegheny Neurological Association)

    Pittsburgh, Pennsylvania, 15212

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33952

  • Minnesota Epilepsy Group, PA

    Saint Paul, Minnesota, 55102

  • University of Texas Health Science Center at San Antonio Medical Arts and Research Center

    San Antonio, Texas, 78229

  • Georgia Neurology and Sleep Medicine Associates

    Suwanee, Georgia, 30042

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

  • University of South Florida

    Tampa, Florida, 33606

  • Vero Beach Neurology And Reasearch Institue/The MS Center of Vero Beach

    Vero Beach, Florida, 32960

  • Clinical Research Center of NJ (CRCNJ)

    Voorhees Township, New Jersey, 08043

  • Balijeet Shethi, MD

    Waldorf, Maryland, 20603

  • George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Wake Forest Baptist Health Sciences, Department of Neurology

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada2 sites

  • Clinique D'Épilepsie Neuro Rive-Sud

    Greenfield Park, Quebec, J4V 2J2

  • Londo Health Sciences Centre, University Hospital

    London, Ontario, N6A 5A5

Other trials in Canada

About this study

Official title: Efficacy and Safety of Eslicarbazepine Acetate as First Add-on to Levetiracetam or Lamotrigine Monotherapy or as Later Adjunctive Treatment for Subjects With Uncontrolled Partial-onset Seizures: A Multicenter, Open-label, Non-randomized Trial

A study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures

Read the 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

Being tested
Eslicarbazepine acetate
Keywords
epilepsy, seizures, partial on-set seizures
Medical subject headings
Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eslicarbazepine acetateDrug

    Also called Aptiom, ESL, SEP-0002093, BIA-2-093

    eslicarbazepine acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 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 AcetateDrug

    Also called Aptiom, ESL, SEP-0002093, BIA-2-093

    eslicarbazepine acetate acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 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)

Study groups in NCT03116828
Study groupRoleWhat they receive
eslicarbazepine acetate (arm 1)Experimentaleslicarbazepine 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)
Receives: Drug: Eslicarbazepine acetate
eslicarbazepine acetate (arm 2)Experimentaleslicarbazepine acetate (as later add-on)
Receives: Drug: Eslicarbazepine acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Number of Subjects Completing 24 Weeks Adjunctive Therapy During 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

    Measured: From the date of the first dose of the study drug until the completion of 24 weeks Maintenance Phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2017
  2. Study start7 Jul 2017
  3. Primary completion6 Jun 2019
  4. Study completion6 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Arm 1 (ESL as first add-on) Arm 2 (ESL as later add-on)
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03116828
Sponsor's protocol ID
093-701
Status last verified
Jun 2020
First submitted
12 Apr 2017
Last updated
16 Jun 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Eslicarbazepine acetate in people with Epilepsy With Partial On-set Seizures, run by Sumitomo Pharma America, Inc. at 55 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase (time frame: From the date of the first dose of the study drug until the completion of 24 weeks Maintenance Phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03116828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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