To Evaluate The Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Phase 3

Completed

• Conditions: Refractory Partial Seizures
• Interventions: Drug: Placebo; Drug: E2007 (perampanel)

• Registration Number: NCT00699582
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Disposition First Submitted: 2012-08-23
• Disposition First Submitted QC: 2012-08-23
• Disposition First Posted: 2012-08-30
• Status Verified: 2012-10
• Results First Submitted: 2012-10-23
• Results First Submitted QC: 2012-10-23
• Results First Posted: 2012-11-22
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

Inclusion Criteria

Not provided

Exclusion Criteria

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

1. Participated in a study involving administration of an investigational compound or device within 1 month (or no less than 21 days) prior to Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
2. Pregnant and/or lactating.
3. Participated in previous perampanel studies.
4. Presence of nonmotor simple partial seizures only.
5. Presence of primary generalized epilepsies or seizures, such as absences and or myoclonic epilepsies.
6. Presence or previous history of Lennox-Gastaut syndrome.
7. A history of status epilepticus within approximately 12 months prior to Visit 1.
8. Seizure clusters where individual seizures cannot be counted.
9. A history of psychogenic seizures.
10. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject's safety or the study conduct.
11. Scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however those who have previously documented "failed" epilepsy surgery will be allowed.
12. Evidence of significant active hepatic disease. 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 3 times the upper limit of normal (ULN).
13. Evidence of significant active hematological disease; white blood cell (WBC) count <= 2500/µL (2.50 1E+09/L) or an absolute neutrophil count <= 1000/µL (1.00 1E+09/L).
14. A clinically significant ECG abnormality, including prolonged QTc defined as >450 msec.
15. Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of antipsychotics or have had a suicide attempt(s) within approximately the last 2 years.
16. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
17. History of drug or alcohol dependency or abuse within approximately the last 2 years.
18. Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
19. If felbamate is used as a concomitant AED, subjects must be on felbamate for at least 2 years, with a stable dose for 2 months (or no less than 49 days) prior to Visit 1. They must not have a history of white blood cell (WBC) count below 2500/µL (2.50 1E+09/L), platelets below 100,000, liver function tests (LFTs) above 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If subjects received felbamate in the past, it must have been discontinued 2 months (or no less than 49 days) prior to Visit 1.
20. Concomitant use of vigabatrin. Subjects who took vigabatrin in the past must be off vigabatrin for approximately 5 months prior to Visit 1 and must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test.
21. Concomitant use of barbiturates (except for seizure control indication) within 1 month (or no less than 21 days) prior to Visit 1.
22. Use of intermittent rescue benzodiazepines (ie, 1-2 doses over a 24-hr period considered one-time rescue) 2 or more times in a 1-month period prior to Visit 1; or
23. Any condition(s) that will make the subject, in the opinion of the Investigator, unsuitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
2	E2007 (perampanel)	-
1	E2007 (perampanel)	-

Primary Outcome Measures

Name	Time	Method
Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)	Baseline (Pre-randomization) through Week 19	Seizure frequency per 28 days was derived from the information recorded in the subject diaries.

Secondary Outcome Measures

Name	Time	Method
Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)	Baseline (Pre-randomization) through Week 19	Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
Responder Rate	Baseline (Pre-randomization) through Week 19	The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre-randomization phase.

Trial Locations

Locations (13)

North Alabama Neuroscience Research Associates; 🇺🇸 Huntsville, Alabama, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Neurosearch II, Inc.; 🇺🇸 Ventura, California, United States

Mile High Research Center; 🇺🇸 Denver, Colorado, United States

Neurology Associates of Northern Colorado; 🇺🇸 Fort Collins, Colorado, United States

Mayo Clinic-Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Dean Foundation for Health, Research and Education, Inc.; 🇺🇸 Madison, Wisconsin, United States

NYU Comprehensive Epilepsy Center; 🇺🇸 New York, New York, United States

Saint Luke's Comprehensive Epilepsy Center; 🇺🇸 Kansas City, Missouri, United States

The Comprehensive Care Center for Children And Adults; 🇺🇸 Chesterfield, Missouri, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Xenoscience, Inc.; 🇺🇸 Phoenix, Arizona, United States

Neurological Research Center at Hattiesburg Clinic; 🇺🇸 Hattiesburg, Mississippi, United States