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

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: Terminated
• Conditions: Refractory Partial Onset Seizures
• Intervention / Treatment: Drug: Rufinamide

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline 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

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2007
• Primary Completion (Actual): May 14, 2010
• Study Completion (Actual): May 14, 2010

Study Registration Dates

• First Submitted: March 15, 2007
• First Submitted That Met QC Criteria: March 15, 2007
• First Posted (Estimate): March 19, 2007

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Refractory Partial Onset Seizures, epilepsy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Rufinamide
• Other Study ID 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