A 4-Year Open-Label Extension (OLE) Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 as an Adjunctive Therapy in Patients With Refractory Partial Seizures
- Conditions
- Epilepsyuncontrolled seizures10028037
- Registration Number
- NL-OMON38093
- Lead Sponsor
- Eisai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
1. Provide written informed consent signed by the patient or legal guardian prior to entering the OLE study or undergoing any study procedures.
2. Have completed all scheduled visits up to and including Visit 8 in the E2007-A001-206 study or Visit 9 of the E2007-G000-208 study.
3. Are reliable and willing to make themslves available for the study period ans are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events.
4. Male and female patients will be eligible for enrollment. Females of childbearing potential must continue practicing a medically acceptable method of contraception (eg. a barrier method plus spermicide, or IUD) and for two months after the end of the OLE study. tThose women using hormonal contraceptive must also continue using an additional approved method of contraception (eg. a barrier method plus spermicide, or IUD) starting with the Titration Phase and continuing throughout the entire study period (revised per Amendment 2)
5. Are between the ages of 18 and 70 years of age, inclusive.
6. Are at least 40 kg (88lb) of weight.
7. Are currently being treated with a stable dose of one, or a maximum of three, marketed and approved AEDs and are known to take their medication(s) as directed (revised per Amendment 4).
1. Show evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigator(s) could affect the patient's safety or trial conduct.
2. Show evidence of significant active hepatic disease and/or bilirubin > 1.5 mg/dL. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less then two times the upper limit of normal (ULN).
3. Show evidence of significant active hematological disease. White blood cell (WBC) count cannot be (<=2500/microliter (2.50 1E+09/L) or an absolute neutrophil count <=1000/microliter (1.00 1E+09/L) (revised per Amendment 3)
4. Clinically significant ECG abnormality, including prolonged QTc (defined as>=450 msec) (revised per Amendments 03 and 04)
5. Presence of major active psychiatric disease. Patients taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed (revised per Amendment 03)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety will be assessed by the nature, frequency, and intensity of adverse<br /><br>events, vital signs, clinical laboratory tests, physical and neurological<br /><br>examinations, and 12-lead ECGs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy will be assessed by the change in partial seizure frequency from<br /><br>Baseline in the E2007-A001-206 or the E2007-G000-208 studies to the OLE<br /><br>Maintenance Phase.</p><br>