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EpilepsyPhase 3NCT00334958

Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures

A Phase 3 study testing Rufinamide in people with Epilepsy, run by Eisai Inc. at 77 sites in United States.

Completed

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

Official record
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Trial summary

To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs). Read more about this study

Who is it for?
Ages 12 to 80 years
Conditions the study is for
Epilepsy
What is being tested?
Rufinamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
356 participants
Where
77 sitesUnited States
Study dates
13 Feb 2006to 20 May 2009
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 12 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male and female patients between 12 and 80 years of age, inclusive.
  • Diagnosis of epilepsy with partial-onset seizures with or without secondarily generalized seizures according with the International League Against Epilepsy Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging (CT/MRI) of the brain performed within the last 10 years and consistent with localization-related epilepsy.
  • Non-controlled partial seizures despite having been treated with at least two different antiepileptic drugs (given concurrently or sequentially) for at least two years.
  • Patient willing to participate and written consent signed by patient or legal guardian prior to entering the study or undergoing any study procedures. If the written consent is provided by a legal guardian because the patient is unable to do so, assent of the patient must also be obtained.
  • Reliability and willingness of patients to make themselves available for the study period, and ability to record seizures and report adverse events themselves or have a caregiver who can record seizures and report adverse events.
  • Female patients of non-childbearing potential by reason of surgery, radiation, or menopause (at least one year post onset); or of childbearing potential using two approved methods of contraception (such as an intrauterine device [IUD], implant, oral contraceptive, or barrier method plus spermicide). Use of a low-dose estrogen oral contraceptive ("minipill") alone will not be permitted. Female patients of childbearing potential must have a confirmed negative serum pregnancy test at screening and a negative urine pregnancy test prior to randomization, and agree to continue to use two approved methods of contraception through the follow-up visit (Visit 8) or for 30 days after their final dose of study medication, whichever is longer.
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  • At least six seizures during the prospective Baseline Phase (56 days) with no 21-day seizure-free periods. Simple partial seizures without motor signs will not be included in determining this criterion.
  • Current treatment with a maximum of three approved antiepileptic drugs, and no evidence of non-compliance with ongoing AED therapy.
  • Stable dose(s) of the same AED(s) for one month prior to screening.
  • If using a vagal nerve stimulator, it must have been implanted for at least six months prior to randomization. Stimulator parameters may not be changed for at least one month prior to screening or thereafter during the study. Magnet use will be allowed, but must be documented throughout the study. A vagal nerve stimulator will not be counted as an AED for the purpose of inclusion into the trial.

Who cannot join

  • Participation in a study involving administration of an investigational compound within one month of Visit 1 (Screening), or within five half-lives of the previous investigational compound, whichever is longer; or any prior exposure to rufinamide.
  • Presence of non-motor simple partial seizures only.
  • Presence of generalized epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
  • History of status epilepticus in the past year or seizure clusters where individual seizures cannot be counted.
  • Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic, hematologic or renal disease, etc.) that in the opinion of the Investigator could affect the patient's safety or trial conduct.
  • Clinically significant ECG abnormality.
Show all 18Show fewer
  • Patients with a diagnosis of major active psychiatric disease will be excluded from the study. However, those patients who are only taking a stable dose of either a selective serotonin reuptake inhibitor (SSRI) antidepressant drug or a serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressant drug for a diagnosed depressive disorder can be included as long as they have been on the SSRI or SNRI for a period of two months or longer before randomization. Other antidepressant medications will not be allowed.
  • Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  • Occurrence of psychogenic seizures in the previous year.
  • History of drug abuse and/or positive finding on urinary drug screening, other than prescribed medication
  • History of alcohol abuse in the past two years.
  • History of suicide attempt within the previous 10 years.
  • Multiple drug allergies (dermatological, hematological or organ toxicity) or more than one severe drug reaction(s).
  • Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
  • Frequent need of rescue benzodiazepines (more than once a month).
  • Patients with a known hypersensitivity to rufinamide, triazole derivatives, or to any excipients used in the formulation.
  • Concomitant use of vigabatrin. Patients who took vigabatrin in the past must be off vigabatrin for at least five months prior to Visit 1 and must not have evidence of a clinically significant abnormality in a visual perimetry test.
  • All Patients with a diagnosis of Congenital Short QT Syndrome. Patients with a family history of Congenital Short QT Syndrome may be excluded on the basis of the Investigator's clinical judgment.

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Blair Medical Associates, Inc.

    Altoona, Pennsylvania, 16602

  • Mcfarland Clinic

    Ames, Iowa, 50010

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806

  • Child Neurology Associates, PC

    Atlanta, Georgia, 30342

  • Medical College of Georgia, Dept. of Neurology

    Augusta, Georgia, 30912

  • John Hopkins Hospital, Dept. of Neurology

    Baltimore, Maryland, 21287

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

  • Boston University Medical Center, Dept. of Neurology

    Boston, Massachusetts, 02118

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • University of Vermont, College of Medicine, Clinical Neurophysiology Lab

    Burlington, Vermont, '05401

  • Fletcher Allen Healthcare

    Burlington, Vermont

  • Medical Associates of North Georgia

    Canton, Georgia, 30114

  • University of North Carolina at Chapel Hill, Dept. of Neurology

    Chapel Hill, North Carolina, 27599-7025

  • The Comprehensive Epilepsy Care Center for Children and Adults

    Chesterfield, Missouri, 63017

  • Children's Memorial Hospital, Northwest University

    Chicago, Illinois, 60614-3394

  • Cleveland Clinic Foundation, Dept. of Neurology

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • Neurological Clinic of Texas, PA

    Dallas, Texas, 75230

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9034

  • Duke Health Center at Morreene Road

    Durham, North Carolina, 27710

  • Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry

    El Paso, Texas, 79905

  • Neuro-Pain Medical Center, Inc.

    Fresno, California, 93710

  • University of Florida, Dept. of Neurology

    Gainesville, Florida, 32611

  • Mid-South Physicians Group, PLLC

    Germantown, Tennessee, 38138

  • Ronald Schwartz, M.D.

    Hattiesburg, Mississippi, 39401

  • Hattiesburg Clinic

    Hattiesburg, Mississippi

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Massachusetts, Neurology Associates

    Hopedale, Massachusetts, 01747

  • University of Texas - Dept of Neurology

    Houston, Texas

  • Baylor Medical Center of Irving

    Irving, Texas, 75061

  • University of Florida, The Neuroscience Institute at Shands

    Jacksonville, Florida, 32209

  • Five Towns Neuroscience Research

    Lawrence, New York, 11559

  • Dartmouth Medical School Neuroscience Center

    Lebanon, New Hampshire, 03756-0001

  • University of Kentucky, Dept. of Neurology

    Lexington, Kentucky, 40536-0284

  • Clinical Trials, Inc

    Little Rock, Arkansas, 72205

  • Pediatric Neurologists of Palm Beach

    Loxahatchee Groves, Florida, 33470

  • University of Wisconsin, Dept. of Neurology

    Madison, Wisconsin, 53792

  • University of Tennessee Health Sciences Center, Dept. of Neurology

    Memphis, Tennessee, 38105

  • UT Medical Group

    Memphis, Tennessee

  • University of Minnesota, Dept. of Neurology

    Minneapolis, Minnesota, 55455

  • University of South Alabama Medical Center

    Mobile, Alabama, 36693

  • Access Clinical Trials, Inc

    Nashville, Tennessee, 37203

  • New York University Medical Centre, Comprehensive Epilepsy Center

    New York, New York, 10016

  • Weill Cornell Medical Center, Comprehensive Epilepsy Center

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Neurology Clinic PC

    Northport, Alabama, 35476

  • Advocate Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Neurology Center

    Oceanside, California, 92056

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nemours Children's Clinic

    Orlando, Florida, 32835

  • Pediatric Neurology - PA

    Orlando, Florida

  • Bay Medical Center

    Panama City, Florida, 32405

  • Advocate Lutheran General Children's Hospital

    Park Ridge, Illinois, 60068

  • Hospital of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4204

  • Hospital of the University of Pennsylvania, Dept. of Neurology

    Philadelphia, Pennsylvania, 19104-4283

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Mayo Clinic Epilepsy and Neurology

    Phoenix, Arizona, 85054

  • Children's Hospital of Pittsburgh - Dept of Pediatrics

    Pittsburgh, Pennsylvania

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University

    Richmond, Virginia, 23298-0211

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Minnesota Epilepsy Group, PC

    Saint Paul, Minnesota, 55102

  • California Pacific Epilepsy

    San Francisco, California, 94115

  • University of Washington, Harborview Medical Center, Regional Epilepsy Center

    Seattle, Washington, 98105

  • Southern Illinois University Neurology and Pharmacology

    Springfield, Illinois, 62794-9643

  • Saint John's Medical Research

    Springfield, Missouri, 65807

  • Saint Louis University

    St Louis, Missouri, 63110

  • Washington University

    St Louis, Missouri, 63110

  • University of Southern Florida, Dept. of Neurology

    Tampa, Florida, 33606

  • Montefiore Medical Center, Albert Einstein College of Medicine

    The Bronx, New York, 10467

  • Medical University of Ohio at Toledo, Dept. of Neurology

    Toledo, Ohio, 43614

  • University of Arizona, Dept. of Neurology

    Tucson, Arizona, 85724-5023

  • Georgetown University Hospital, Dept. of Neurology

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Epilepsy and Neurodevelopment, Inc.

    West Jordan, Utah, 84088

  • Via Christi Comprehensive Epilepsy Center

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).

Conditions
Epilepsy
Being tested
Placebo, Rufinamide
Medical subject headings
Epilepsy

What participants receive

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

  • PlaceboDrug

    For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 placebo tablets twice daily.

  • RufinamideDrug

    Also called E2080, BANZEL

    For the titration phase, Rufinamide will be administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).

Study groups in NCT00334958
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFor 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets will be administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet will be administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
Receives: Drug: Placebo
RufinamideActive comparatorFor the 12-day Titration Phase, rufinamide will be administered orally in doses starting with 400 milligram (mg) twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
Receives: Drug: Rufinamide

What is being measured

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

  1. Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase

    Seizure data was collected via patient diary, which was used to record daily seizure count and type. Intent-to-treat (ITT) population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.

    Measured: Baseline, Days 13 to 96

Secondary outcomes (3)

  1. Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase

    Seizure data was collected via patient diary, which was used to record daily seizure count and type.

    Measured: Baseline, Days 13 to 96

  2. Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase

    Total partial seizure frequencies per 28 days during the double-blind Maintenance and Baseline Phases were transformed using logarithms to the base 10 (log10), because it was expected from previous studies that the results would not be normally distributed.

    Measured: Days 13 to 96

  3. Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase

    RRATIO= 100*(T-B)/(T+B) where T= total seizure frequency per 28 days during the Maintenance Phase, and B=total seizure frequency per 28 days during the Baseline Phase.

    Measured: Baseline, Days 13 to 96

Timeline

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

  1. First posted8 Jun 2006 (estimated)
  2. Study start13 Feb 2006
  3. Primary completion20 May 2009
  4. Study completion20 May 2009

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
Double blind
Who is masked
Participant, Investigator
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334958
Sponsor's protocol ID
E2080-A001-301
Other IDs
2016-004944-12, 2016
Status last verified
May 2021
First submitted
7 Jun 2006
Last updated
14 Jun 2021
Data monitoring committee
No

Publications

  • Panebianco M, Prabhakar H, Marson AG. Rufinamide add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Nov 8;11(11):CD011772. doi: 10.1002/14651858.CD011772.pub3.

    PubMed 33179247

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rufinamide in people with Epilepsy, run by Eisai Inc. at 77 sites in United States.

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 10 inclusion and 18 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. 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. Some participants in this study may receive a placebo. 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 5 Feb 2013). 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?

Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase (time frame: Baseline, Days 13 to 96). 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 NCT00334958, 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 14 Jun 2021.

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