4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
NCT ID: NCT00368472
Last Updated: 2015-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2006-10-31
2014-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Perampanel
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
Perampanel
Perampanel 2 mg to 12 mg, once daily during the OLE study
Interventions
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Perampanel
Perampanel 2 mg to 12 mg, once daily during the OLE study
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
70 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Denver, Colorado, United States
Bradenton, Florida, United States
Melbourne, Florida, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
New Hyde Park, New York, United States
Columbus, Ohio, United States
West Jordan, Utah, United States
Burlington, Vermont, United States
Chatswood, New South Wales, Australia
Maroochydore, Queensland, Australia
Woodville, South Australia, Australia
Edegem, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Tielt, , Belgium
Brno, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Rychnov nad Kněžnou, , Czechia
Tallinn, , Estonia
Tartu, , Estonia
Kuopio, , Finland
Tampere, , Finland
Lille, , France
Montpellier, , France
Ramonville-Saint-Agne, , France
Berlin, , Germany
Göttingen, , Germany
München, , Germany
Ulm, , Germany
Riga, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Rotterdam, , Netherlands
Valencia, , Spain
Stockholm, , Sweden
Dundee, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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E2007-A001-207
Identifier Type: -
Identifier Source: org_study_id