Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

November 13, 2019 updated by: Eisai Inc.

An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36693
        • University of South Alabama Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials, Inc.
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center
      • Jacksonville, Florida, United States, 32209
        • University of Florida, The Neuroscience Institute at Shands
      • Loxahatchee Groves, Florida, United States, 33470
        • Pediatric Neurologists of Palm Beach
      • Orlando, Florida, United States, 32835
        • Pediatric Neurosciences, PA
      • Panama City, Florida, United States, 32405
        • Bay Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Child Neurology Associates, PC
    • Illinois
      • Springfield, Illinois, United States, 62794-9643
        • Southern Illinois University Neurology and Pharmacology
    • Iowa
      • Ames, Iowa, United States, 50010-3014
        • McFarland Clinic PC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins Hospital, Dept. of Neurology
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Comprehensive Epilepsy Care Center for Children and Adults
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Dartmouth Medical School Neuroscience Center
    • New York
      • Cedarhurst, New York, United States, 11516
        • Five Towns Neuroscience Research
      • New York, New York, United States, 10016
        • New York University Medical Centre, Comprehensive Epilepsy Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center, Comprehensive Epilepsy Center
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Asheville Neurology Specialists
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Toledo, Ohio, United States
        • Medical University of Ohio at Toledo - Dept. of Neurology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4204
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania Medical Center-Department of Neurology
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • University of Tennessee Health Sciences Center, Dept. of Neurology
      • Nashville, Tennessee, United States, 37203
        • Access Clinical Trials, Inc
    • Texas
      • Dallas, Texas, United States, 75230
        • Neurological Clinic of Texas, P.A.
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  1. Completion of Study E2080-A001-301 and full compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
  2. Patient willing to participate and written consent signed by patient or legal guardian provided prior to entering this study or undergoing any study procedures. In addition, if the patient is unable to provide written informed consent and it is provided by a legal guardian, assent of the patient (if the patient is able) must also be obtained.
  3. Female patients of non-childbearing potential by reason of surgery, radiation, or menopause (at least one year post onset); female patients of childbearing potential who are using at least 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 alone will not be permitted. Female patients of childbearing potential must agree to continue to use two approved methods of contraception through the follow-up visit or for 30 days after their final dose of study medication, whichever is longer.

EXCLUSION CRITERIA:

  1. Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
  2. Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
  3. Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic (e.g., ALT > 3x ULN), hematologic, renal, or psychiatric disease, etc.) that in the opinion of the Investigator could affect the patient's safety or trial conduct.
  4. Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  5. History of alcohol abuse in the past 2 years.
  6. History of suicide attempt within the previous 10 years.
  7. Multiple drug allergies (dematological, heatological or organ toxicity) or more than one severe drug reaction.
  8. Concomitant use of felbamate or vigabatrin.
  9. Pregnancy.
  10. Clinically significant ECG abnormality.
  11. 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 judgement.
  12. Presence of major active psychiatric disorder. Patients will be allowed who are taking a stable dose of selective serotonin reuptake inhibitor (SSRI) or mixed serotonin and norepinephrine uptake inhibitor antidepressant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rufinamide (Rufinamide During Core Study)
Drug: Rufinamide
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Other Names:
  • E2080
Experimental: Rufinamide (Placebo During Core Study)
Drug: Rufinamide
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Other Names:
  • E2080

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
Time Frame: Baseline, Titration Phase (Days 1 to 18), Maintenance Phase
Seizure data was collected via patient diaries. "OL" refers to "open-label."
Baseline, Titration Phase (Days 1 to 18), Maintenance Phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2080-A001-302
  • 2016-004950-14 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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