Clinical trial NCT00448539: Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Official title: An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Refractory Partial Onset Seizures
Keywords: Refractory Partial Onset Seizures, epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 286
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
timeFrame: Baseline, Titration Phase (Days 1 to 18), Maintenance Phase
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida, The Neuroscience Institute at Shands
state: Florida
city: Loxahatchee Groves
country: United States
facility: Pediatric Neurologists of Palm Beach
state: Florida
city: Orlando
country: United States
facility: Pediatric Neurosciences, PA
state: Florida
city: Panama City
country: United States
facility: Bay Medical Center
state: Florida
city: Atlanta
country: United States
facility: Child Neurology Associates, PC
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University Neurology and Pharmacology
state: Illinois
city: Ames
country: United States
facility: McFarland Clinic PC
state: Iowa
city: Baltimore
country: United States
facility: John Hopkins Hospital, Dept. of Neurology
state: Maryland
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Chesterfield
country: United States
facility: Comprehensive Epilepsy Care Center for Children and Adults
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Medical School Neuroscience Center
state: New Hampshire
city: Cedarhurst
country: United States
facility: Five Towns Neuroscience Research
state: New York
city: New York
country: United States
facility: New York University Medical Centre, Comprehensive Epilepsy Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center, Comprehensive Epilepsy Center
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Toledo
country: United States
facility: Medical University of Ohio at Toledo - Dept. of Neurology
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of The University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center-Department of Neurology
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Sciences Center, Dept. of Neurology
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc
state: Tennessee
city: Dallas
country: United States
facility: Neurological Clinic of Texas, P.A.
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Healthcare
state: Vermont
Study officials:
References: