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EpilepsyPhase 3NCT01091662

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

A Phase 3 study testing Eslicarbazepine acetate 1600 mg and Eslicarbazepine acetate 1200 mg in people with Epilepsy, run by Sumitomo Pharma America, Inc. at 62 sites in 5 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

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. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Epilepsy
What is being tested?
Eslicarbazepine acetate 1600 mg and Eslicarbazepine acetate 1200 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
62 sitesin 5 countries
Study dates
Jun 2010to Nov 2012
Phase
Phase 3
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 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

62 sites in 5 countries.

62 sites in 5 countries

United States39 sites

  • Community Clinical Research Inc.

    Austin, Texas, 78754

  • Kern County Neurological Medical Group, INC.

    Bakersfield, California, 93301

  • The Sandra and Malcom Berman Brain & Spine Institute

    Baltimore, Maryland, 21209

  • Brownwood Regional Medical Center

    Brownwood, Texas, 76801

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Ohio Clinical Research Partners, LLC

    Canton, Ohio, 44718

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Arkansas Neurology

    Conway, Arkansas, 72034

  • MD

    Dallas, Texas, 75214

  • Vital Clinical Research

    DeSoto, Texas, 75115

  • Wayne State University/Detroit Medical Center

    Detroit, Michigan, 48201

  • Specialty Nuerology, PC

    Englewood, Colorado, 80113

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Minneappolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • East Carolina Neurology

    Greenville, North Carolina, 27834

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601

  • Palm Springs Research Institute, Inc

    Hialeah, Florida, 33012

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana, 46237

  • University of Kentucky Department of Neurology

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • West Los Angeles VA Medical Center

    Los Angeles, California, 90073

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Pharma Care Research LLC

    Miami, Florida, 33165

  • Regional Epilepsy Center

    Milwaukee, Wisconsin, 53215

  • UMDNJ DOC 8th Floor 8100

    Newark, New Jersey, 07103

  • Dent Neurologic Institute

    Orchard Park, New York, 14127

  • Bay Neurological Institute

    Panama City, Florida, 32405

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Temple University School of Medicine

    Philadelphia, Pennsylvania, 19140

  • Global Medical Institutes, LLC

    Princeton, New Jersey, 08540

  • Louisiana State University Health Science Center - Shreveport

    Shreveport, Louisiana, 71103

  • SUNY Upstate Medical University Department of Neurology

    Syracuse, New York, 13210

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Shore Neurology, PA

    Toms River, New Jersey, 08755

  • University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Tulsa Clinical Research LLC

    Tulsa, Oklahoma, 74104

  • Loveland Scientific Resources Inc.

    Venice, Florida, 34292

  • Neurosearch II Inc.

    Ventura, California, 93003

Other trials in United States

Ukraine11 sites

  • 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, 49005

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

    Donetsk, Donetsk Oblast, 83008

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

    Kharkiv, Kharkiv Oblast, 61068

  • State Treatment and Prevention Institution

    Kharkiv, Kharkov, 61018

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

    Kharkiv, Kharkov, 61153

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

    Kiev, Kyiv City, 01030

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

    Lviv, Lviv Oblast, 79021

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

    Odesa, Odesa Oblast, 65006

  • Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev

    Poltava, Poltava Oblast, 36003

  • Crimean Republic Institution "Clinical Psychiatric Hospital #1"

    Simferopol, Simferopol, 95006

  • 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, 21005

Other trials in Ukraine

Czechia6 sites

  • Neurologicka ordinance

    Kolejni, Prague, 160 00

  • Poradna pro epilepsie

    Koterova, Zin, 760 01

  • Cerebrovaskularni poradna s.r.o.

    Ostrava, Tiebovice, 72200

  • Study site

    Prague, Pocernicka, 1427 16

  • CTC Rycnov nad Kneznou

    Rychnov nad Kněžnou, Praugue, 516 01

  • Policlinic Chocen, private neurology

    Smetanova, Chocen, 56501

Other trials in Czechia

Bulgaria4 sites

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

    Blagoevgrad, Bulgaria, 2700

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

    Pleven, Pleven, 5800

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

    Sofia, Bulgaria, 1202

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

    Varna, Varna, 9000

Other trials in Bulgaria

Serbia2 sites

  • Clinic of Neurology, Clinical Center of Serbia

    Belgrade, Belgrade, 11000

  • Institute of Mental Health, Department of epilepsy and clinical neurophysiology

    Palmoticeva, Belgrade, 11000

Other trials in Serbia

About this study

Official title: Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

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.

Read the 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
Being tested
Eslicarbazepine acetate 1600 mg, Eslicarbazepine acetate 1200 mg
Keywords
Seizures, Epilepsy, Anticonvulsant, Monotherapy, Historical control
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 acetate 1600 mgDrug

    1600 mg once per day

  • Eslicarbazepine acetate 1200 mgDrug

    1200 once per day

Study groups in NCT01091662
Study groupRoleWhat they receive
eslicarbazepine acetate 1600 mgExperimentalSubjects 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.
Receives: Drug: Eslicarbazepine acetate 1600 mg
eslicarbazepine acetate 1200 mgExperimentalSubjects 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.
Receives: Drug: Eslicarbazepine acetate 1200 mg

What is being measured

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

  1. Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method

    Cumulative exit rate was defined as the proportion of subjects meeting at least one of the following five exit criteria over a 16-week study period (from start of AED taper/con. period (Wk 3) to end of double blind monotherapy period (Wk 18)).1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.

    5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator

    Measured: From beginning of Week 3 to end of Week 18

Secondary outcomes (15)

  1. Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.

    Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.

    Measured: Week 9 through 18

  2. Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.

    Percentage of participants that were Seizure-free during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.

    Measured: Week 15 through 18

  3. Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment).

    Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.

    Measured: 18 weeks

  4. Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete).

    Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.

    Measured: Week 8 through 18

  5. Time on Eslicarbazepine Acetate Monotherapy.

    The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.

    Measured: Week 8 to Week 18

  6. Change in Seizure Frequency From Baseline.

    The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).

    Measured: 18 weeks, Double-blind:weeks 1-18; Baseline: weeks -8to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy; weeks 9 to 18

  7. Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).

    Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.

    Measured: Week 0 to Week 18, Double-blind weeks 1-18; baseline: weeks -8 to -1; Titration: weeks 1-2; AED taper/conversion; weeks 3-8; monotherapy weeks 9-18

  8. Proportion (%) of Subjects Reaching Each Exit Criteria

    The proportion (%) of subjects reaching each of the 5 exit criteria-1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.

    5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator

    Measured: Week 1 to Week 18, (beginning of week 1 to end of week 18)

  9. Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).

    The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.

    Measured: Week 0 to Week 18, Baseline: Day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18

  10. Change in Total Score in Montgomery-Asberg Depression Rating Scale (MADRS),From Baseline .

    The total score of MADRS is defined as the sum of all individual item scores. From 0-60, high score indicates more severe

    Measured: Week 0 to Week 18,baseline day 0; end of AED taper/conversion period; end of week 8; end of monotherapy period; end of week 18

  11. Change in Total Score of MADRS From Baseline in Those Subjects With a MADRS Score of ≥14 at Randomization.

    The total score of MADRS is defined as the sum of all individual item scores. From 0-60, higher score indicates more severe

    Measured: Week 0 to Week 18, baseline:day 0;end of AED taper/conversion period; end of week 8; end of monotherapy period: end of week 18

  12. Proportion (%) of Subjects With Increase of Body Weight >= 7% From Baseline

    Measured: 18 Week Double-blind treatment period

  13. Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L.

    Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L

    Measured: Week 0 to Week 18

  14. Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).

    Measured: 18 Week Double-blind treatment period

  15. Standardized Seizure Frequency (SSF) by Period

    Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).

    Measured: Double-blind: week to 18; Baseline: weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion weeks 3 to 8; monotherapy: weeks 9 to 18

Timeline

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

  1. First posted24 Mar 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionNov 2012
  4. Study completionNov 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01091662
Sponsor's protocol ID
093-046
Status last verified
Sep 2016
First submitted
17 Mar 2010
Last updated
24 Oct 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 25880756

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eslicarbazepine acetate 1600 mg and Eslicarbazepine acetate 1200 mg in people with Epilepsy, run by Sumitomo Pharma America, Inc. at 62 sites in 5 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 17 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Ukraine, Czechia, Bulgaria, Serbia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Dec 2015). 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?

Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method (time frame: From beginning of Week 3 to end of Week 18). 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 NCT01091662, which also lists 1 linked publication.

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 24 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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