Research study to investigate an additional treatment for patients with epilepsy.

Phase 1

• Conditions: E2007 is given as adjunctive, long-term treatment in patients with refractory partial onset seizures with or without secondary generalization; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2005-004293-24-GB
• Lead Sponsor: Eisai Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Study Completion: 2014-07-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 138

Inclusion Criteria

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 (revised per Amendment 04 and A).

3. Are reliable and willing to make themselves available for the study period and 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, abstinence, a barrier method plus spermicide, or IUD) and for 8 weeks after the end of the study. (revised per Amendment 06) Those women using hormonal contraceptives 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 Amendments 02 and 06).

5. Are between the ages of 18 and 70 years of age, inclusive.

6. Are at least 40 kg (88 lb) in weight (revised per amendment 06).

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 04 and A).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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 than 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 01).

4. Clinically significant ECG abnormality, including prolonged QTc (defined as >= 450 msec). (revised per Amendments 03, 04 and A).

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 clinical trial of medicinal product
• Study Design: Not specified