Clinical trial NCT00368472: 4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
Official title: An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 (Perampanel) as an Adjunctive Therapy in Patients With Refractory Partial Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Refractory
Partial
Seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is an Open-Label Extension (OLE) study for patients who completed the E2007-A001-206 (NCT00144690) or the E2007-G000-208 (NCT00416195) double-blind, placebo-controlled, dose-escalation, parallel-group studies.

This study consisted of 3 periods: OLE Titration (12 weeks), OLE Maintenance (424 weeks), and OLE Follow-up (4 weeks). During the OLE Titration Period, participants were titrated to their maximum tolerated dose (MTD) of perampanel, up to a maximum of 12 mg/day. The OLE Maintenance Period began at completion of the OLE Titration Period; participants remained on the dose achieved at the end of the OLE Titration Period unless dose adjustment for tolerability reasons was necessary. Participants who either withdrew from the study prematurely or completed the OLE Maintenance Period returned for a final visit at the end of the 4-week OLE Follow-up Period.

Eligibility criteria: KEY INCLUSION CRITERIA:

1. 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.
2. 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.
3. 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).
4. Are between the ages of 18 and 70 years of age, inclusive.
5. Are at least 40 kg (88 lb) of weight.
6. 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:

1. 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.
2. 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).
3. 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.
4. Clinically significant ECG abnormality, including prolonged QTc (defined as greater than or equal to 450 msec).
5. Presence of major active psychiatric disease. Participants taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: 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:
measure: Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline
timeFrame: Baseline up to Week 221
measure: Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline
timeFrame: Baseline up to week 221
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Denver
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: New Hyde Park
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: West Jordan
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Chatswood
country: Australia
state: New South Wales
city: Maroochydore
country: Australia
state: Queensland
city: Woodville
country: Australia
state: South Australia
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Tielt
country: Belgium
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Rychnov nad Kneznou
country: Czech Republic
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Kuopio
country: Finland
city: Tampere
country: Finland
city: Lille
country: France
city: Montpellier
country: France
city: Ramonville Saint-Agne
country: France
city: Berlin
country: Germany
city: Gottingen
country: Germany
city: Munchen
country: Germany
city: Ulm
country: Germany
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Rotterdam
country: Netherlands
city: Valencia
country: Spain
city: Stockholm
country: Sweden
city: Dundee
country: United Kingdom
Study officials:
References:
citation: 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.
citation: 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.