Status:
TERMINATED
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Lead Sponsor:
Eisai Inc.
Conditions:
Refractory Partial Onset Seizures
Eligibility:
All Genders
12-80 years
Phase:
PHASE3
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 stud...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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).
- 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.
- 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:
- Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
- Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
- 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.
- Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- History of alcohol abuse in the past 2 years.
- History of suicide attempt within the previous 10 years.
- Multiple drug allergies (dematological, heatological or organ toxicity) or more than one severe drug reaction.
- Concomitant use of felbamate or vigabatrin.
- Pregnancy.
- Clinically significant ECG abnormality.
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
March 15 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2010
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00448539
Start Date
March 15 2007
End Date
May 14 2010
Last Update
November 22 2019
Active Locations (27)
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1
University of South Alabama Medical Center
Mobile, Alabama, United States, 36693
2
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
3
Bradenton Research Center
Bradenton, Florida, United States, 34205
4
University of Florida, The Neuroscience Institute at Shands
Jacksonville, Florida, United States, 32209