4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures - Full Text View

Purpose

The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.

Condition	Intervention	Phase
Epilepsy	Drug: Perampanel	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 4-Year Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 as an Adjunctive Therapy in Patients 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:

Seizure frequency per 28 days [ Time Frame: baseline (study 206 or 208) to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

incidence rates of treatment-emergent adverse events [ Time Frame: baseline (study 206 or 208) to end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	108
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Perampanel	Drug: Perampanel perampanel 2 mg - 12 mg, once daily

Detailed Description:

This is an Open-Label Extension (OLE) study for patients who completed the E2007-A001-206 or the E2007-G000-208 double-blind, placebo-controlled, dose-escalation, parallel-group studies.

For those patients who have completed E2007-A001-206 study, the 207 study will consist of the following phases during the OLE:

OLE Titration Phase (4 weeks): Scheduled visits will be conducted every two weeks for 4 weeks. During this phase, the Investigators will start the E2007 dosing at 2 mg and escalate to 4 mg in two weeks based on patient tolerability and safety.
OLE Maintenance Phase (208 weeks): Scheduled visits will be conducted one month following the completion of OLE titration phase and every 3 months thereafter for a total of 208 weeks. During this phase, patients will continue the highest tolerated dose of E2007 that was established during the OLE Titration Phase.
OLE Safety Phase (one visit): The purpose of this visit (Week 216) is a four-week follow up after the last dose of study drug was administered.

For those patients who have completed E2007-G000-208 study, the 207 study will consist of the following phases during the OLE:

OLE Titration Phase (12 weeks): Scheduled visits will be conducted every two weeks for 12 weeks. Titration will be made in 2 weeks intervals, on the basis of individual tolerance and in 2 mg incremental steps (ie, the patients will titrate from 2 mg to 4 mg to 6 mg to 8 mg to 10 mg to 12 mg).
OLE Maintenance Phase (208 weeks): Scheduled visits will be conducted one month following the completion of OLE titration phase and every 3 months thereafter for a total of 208 weeks. During this phase, patients will continue the highest tolerated dose of E2007 that was established during the OLE Titration Phase.
OLE Safety Phase (one visit): The purpose of this visit (Week 224) is a four-week follow up after the last dose of study drug was administered.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

KEY INCLUSION CRITERIA:

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.
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.
Females of childbearing potential must continue practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or Intrauterine device (IUD)) and for two months after the end of the OLE study. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (e.g., a barrier method plus spermicide, or IUD.
Are between the ages of 18 and 70 years of age, inclusive.
Are at least 40 kg (88 lb) of weight.
Are currently being treated with a stable dose of one, or a maximum of three licensed Anti-epileptic drugs (AEDs) and are known to take their medication(s) as directed.

KEY EXCLUSION CRITERIA:

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.
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).
Show evidence of significant active hematological disease. White blood cell (WBC) count cannot be ≤ 2500/μL (2.50 1E+09/L) or an absolute neutrophil count ≤ 1000/μL (1.00 1E+09/L).
Clinically significant ECG abnormality, including prolonged QTc (defined as ≥ 450 msec).
Presence of major active psychiatric disease. Patients taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368472

Locations

United States, Arkansas
Arkansas Research Program
Little Rock, Arkansas, United States, 72205
United States, Florida
Dept. Of Neurosurgery Clinical Trials, Inc.
Tampa, Florida, United States, 33606
United States, Maryland

Baltimore, Maryland, United States
United States, Michigan
Henry Ford Hospital Dept. of Neurology
Detroit, Michigan, United States, 48202
United States, Ohio
Medical College of Ohio Comprehensive Epilepsy Ctr.
Toledo, Ohio, United States, 43614
United States, Tennessee
USF Physicians Group
Nashville, Tennessee, United States, 37212
United States, Vermont

Burlington, Vermont, United States, 05401

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:	NCT00368472 History of Changes
Other Study ID Numbers:	E2007-A001-207
Study First Received:	August 22, 2006
Last Updated:	March 1, 2013
Health Authority:	United States: Food and Drug Administration European Union: European Medicines Agency

Keywords provided by Eisai Inc.:

Refractory
Partial
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 21, 2013