NCT00368472

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_2

Geographic Reach
13 countries

46 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 10, 2015

Completed
Last Updated

December 10, 2015

Status Verified

November 1, 2015

Enrollment Period

7.7 years

First QC Date

August 22, 2006

Results QC Date

June 26, 2015

Last Update Submit

November 5, 2015

Conditions

Epilepsy

Keywords

RefractoryPartialSeizures

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)

    An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The data is presented in the safety section of the results.

    From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years

Secondary Outcomes (2)

  • Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline

    Baseline up to Week 221

  • Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline

    Baseline up to week 221

Study Arms (1)

Perampanel

EXPERIMENTAL

Participants previously receiving placebo/perampanel in the double blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily during the OLE study

Drug: Perampanel

Interventions

PerampanelDRUG

Perampanel 2 mg to 12 mg, once daily during the OLE study

Perampanel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have completed all scheduled visits up to and including Visit 8 in the E2007-A001-206 (NCT00144690) study or Visit 9 of the E2007-G000-208 (NCT00416195) 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 8 weeks 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.

You may not qualify if:

  • Show evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.,) that, in the opinion of the Investigator(s), could affect the participant's safety or trial conduct.
  • Show evidence of significant active hepatic disease and/or bilirubin greater than 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 less than or equal to 2500/microL or an absolute neutrophil count less than or equal to 1000/microL.
  • Clinically significant ECG abnormality, including prolonged QTc (defined as greater than or equal to 450 msec).
  • Presence of major active psychiatric disease. Participants taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Phoenix, Arizona, 85013, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Bradenton, Florida, 34205, United States

Location

Unknown Facility

Melbourne, Florida, 32901, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

New Hyde Park, New York, 11040, United States

Location

Unknown Facility

Columbus, Ohio, 43210, United States

Location

Unknown Facility

West Jordan, Utah, 84088, United States

Location

Unknown Facility

Burlington, Vermont, 05401, United States

Location

Unknown Facility

Chatswood, New South Wales, 2067, Australia

Location

Unknown Facility

Maroochydore, Queensland, 4558, Australia

Location

Unknown Facility

Woodville, South Australia, 5011, Australia

Location

Unknown Facility

Edegem, 2650, Belgium

Location

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Leuven, B-3000, Belgium

Location

Unknown Facility

Tielt, B-8700, Belgium

Location

Unknown Facility

Brno, 656 91, Czechia

Location

Unknown Facility

Hradec Králové, 500 05, Czechia

Location

Unknown Facility

Olomouc, 775 20, Czechia

Location

Unknown Facility

Ostrava, 708 52, Czechia

Location

Unknown Facility

Prague, 150 06, Czechia

Location

Unknown Facility

Rychnov nad Kněžnou, 516 01, Czechia

Location

Unknown Facility

Tallinn, 10617, Estonia

Location

Unknown Facility

Tartu, EE-51014, Estonia

Location

Unknown Facility

Kuopio, FI-70210, Finland

Location

Unknown Facility

Tampere, FI-33520, Finland

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Ramonville-Saint-Agne, 31520, France

Location

Unknown Facility

Berlin, D-10365, Germany

Location

Unknown Facility

Göttingen, 37075, Germany

Location

Unknown Facility

München, 80333, Germany

Location

Unknown Facility

Ulm, 89081, Germany

Location

Unknown Facility

Riga, LV-1002, Latvia

Location

Unknown Facility

Kaunas, LT-50009, Lithuania

Location

Unknown Facility

Kaunas, LT-50185, Lithuania

Location

Unknown Facility

Klaipėda, LT-92288, Lithuania

Location

Unknown Facility

Šiauliai, LT-76231, Lithuania

Location

Unknown Facility

Vilnius, LT-03215, Lithuania

Location

Unknown Facility

Vilnius, LT-08661, Lithuania

Location

Unknown Facility

Rotterdam, 3012 KM, Netherlands

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Stockholm, 112 45, Sweden

Location

Unknown Facility

Dundee, DD1 9SY, United Kingdom

Location

Related Publications (2)

  • Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

    PMID: 35305920DERIVED

  • Rektor I, Krauss GL, Bar M, Biton V, Klapper JA, Vaiciene-Magistris N, Kuba R, Squillacote D, Gee M, Kumar D. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurol Scand. 2012 Oct;126(4):263-9. doi: 10.1111/ane.12001. Epub 2012 Aug 23.

    PMID: 22913800DERIVED

MeSH Terms

Conditions

EpilepsySeizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Eisai Medical Services
Organization
Eisai, Inc.
esi_medinfo@eisai.com
1-888-422-4743

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 24, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

December 10, 2015

Results First Posted

December 10, 2015

Record last verified: 2015-11

Locations

NL(1)SE(1)FI(2)BE(4)GB(1)DE(4)ES(2)CZ(6)LI(6)AU(3)US(12)FR(3)LA(1)