Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures - Full Text View

Purpose

The purpose of this study is to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

Condition	Intervention	Phase
Epilepsy	Drug: perampanel Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Perampanel

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Primary efficacy will be assessed by seizure counts (using subject's diaries) documenting the percent change in seizure frequency per 28 days. [ Time Frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts between visits. After 16 wks, they will be done every 12 wks w/interim telephone contacts in between. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy measures will evaluate the delayed treatment effect by summarizing previous endpoints over the open-label treatment phase relative to the pre-randomization phase of the double-blind study. [ Time Frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts. After 16 weeks, they will be done every 12 wks w/interim telephone contacts in between. ] [ Designated as safety issue: No ]

Estimated Enrollment:	1443
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: perampanel 2 mg/day, oral administration.
Experimental: 2	Drug: perampanel 4 mg/day, oral administration.
Experimental: 3	Drug: perampanel 6 mg/day, oral administration.
Experimental: 4	Drug: perampanel 8 mg/day, oral administration.
Experimental: 5	Drug: perampanel 10 mg/day, oral administration.
Experimental: 6	Drug: perampanel 12 mg/day, oral administration.
Placebo Comparator: Placebo	Drug: Placebo Subjects will receive matching placebo tablets.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Each subject must meet all of the following criteria to be enrolled in this study:

Have completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
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).
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.
Females should be either of non-childbearing 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 method 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).
Continue to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs.

Exclusion Criteria:

Subjects who meet the following criteria will be excluded from the study:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735397

Show 28 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Michelle Gee, PhD.

Eisai Limited

More Information

No publications provided

Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00735397 History of Changes
Other Study ID Numbers:	E2007-G000-307
Study First Received:	August 13, 2008
Last Updated:	February 6, 2013
Health Authority:	United States: Food and Drug Administration European Union: European Medicines Agency

Keywords provided by Eisai Inc.:

Partial onset seizures

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013