Refractory Partial Onset Seizures Clinical Trial
Official title:
An Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
| Verified date | November 2019 |
| Source | Eisai Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 286 |
| Est. completion date | May 14, 2010 |
| Est. primary completion date | May 14, 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | McFarland Clinic PC | Ames | Iowa |
| United States | Asheville Neurology Specialists | Asheville | North Carolina |
| United States | Child Neurology Associates, PC | Atlanta | Georgia |
| United States | John Hopkins Hospital, Dept. of Neurology | Baltimore | Maryland |
| United States | Bradenton Research Center | Bradenton | Florida |
| United States | Fletcher Allen Healthcare | Burlington | Vermont |
| United States | Five Towns Neuroscience Research | Cedarhurst | New York |
| United States | Comprehensive Epilepsy Care Center for Children and Adults | Chesterfield | Missouri |
| United States | Ohio State University | Columbus | Ohio |
| United States | Neurological Clinic of Texas, P.A. | Dallas | Texas |
| United States | Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry | El Paso | Texas |
| United States | Hattiesburg Clinic | Hattiesburg | Mississippi |
| United States | University of Florida, The Neuroscience Institute at Shands | Jacksonville | Florida |
| United States | Dartmouth Medical School Neuroscience Center | Lebanon | New Hampshire |
| United States | Clinical Trials, Inc. | Little Rock | Arkansas |
| United States | Pediatric Neurologists of Palm Beach | Loxahatchee Groves | Florida |
| United States | University of Tennessee Health Sciences Center, Dept. of Neurology | Memphis | Tennessee |
| United States | University of South Alabama Medical Center | Mobile | Alabama |
| United States | Access Clinical Trials, Inc | Nashville | Tennessee |
| United States | New York University Medical Centre, Comprehensive Epilepsy Center | New York | New York |
| United States | Weill Cornell Medical Center, Comprehensive Epilepsy Center | New York | New York |
| United States | Pediatric Neurosciences, PA | Orlando | Florida |
| United States | Bay Medical Center | Panama City | Florida |
| United States | Hospital of The University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Medical Center-Department of Neurology | Philadelphia | Pennsylvania |
| United States | Southern Illinois University Neurology and Pharmacology | Springfield | Illinois |
| United States | Medical University of Ohio at Toledo - Dept. of Neurology | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Eisai Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |