Clinical trial using placebo to check if the drug E2007 (perampanel) hasefficacy and if it's safe given to patients with under control epilepsy

• Conditions: Epilepsy: refractory partial seizures with or without secondary generalisation; MedDRA version: 14.1Level: LLTClassification code 10048674Term: Partial seizures with secondary generalizationSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2007-006170-28-BG
• Lead Sponsor: Eisai Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-13
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1430

Inclusion Criteria

1. Have completed Visit 8 of study E2007-G000-304, E2007-G000-305 study, or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
2. Provide written informed consent signed by subject or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained);
3. Be considered reliable and willing to be available for the study period and able to record seizures and report adverse events them self or have a caregiver who can record and report the events for them.
4. Females should be either of nonchildbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. For females of childbearing potential, they must agree to be abstinent or continue using at least 1 medically acceptable methods of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (as described previously) throughout the entire study period and for 2 months after the last dose of study drug. (It is not required for male subjects to use contraceptive measures based on preclinical toxicology data).
5. Continue to be treated with a stable dose of 1 or a maximum of 3 approved AEDs.
Are the trial subjects under 18? yes
Number of subjects for this age range: 476
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 478
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 476

Exclusion Criteria

1. Those who, for any reason, discontinued early from the preceding double-blind study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified