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

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ClinicalTrials.gov Identifier: NCT00368472
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Perampanel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2006
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: 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
Drug: Perampanel
Perampanel 2 mg to 12 mg, once daily during the OLE study




Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) [ Time Frame: From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years ]
    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.


Secondary Outcome Measures :
  1. Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline [ Time Frame: Baseline up to Week 221 ]
    Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.

  2. Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline [ Time Frame: Baseline up to week 221 ]
    Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368472


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix, Arizona, United States, 85013
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Bradenton, Florida, United States, 34205
Melbourne, Florida, United States, 32901
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, New York
New Hyde Park, New York, United States, 11040
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Utah
West Jordan, Utah, United States, 84088
United States, Vermont
Burlington, Vermont, United States, 05401
Australia, New South Wales
Chatswood, New South Wales, Australia, 2067
Australia, Queensland
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Woodville, South Australia, Australia, 5011
Belgium
Edegem, Belgium, 2650
Gent, Belgium, 9000
Leuven, Belgium, B-3000
Tielt, Belgium, B-8700
Czech Republic
Brno, Czech Republic, 656 91
Hradec Kralove, Czech Republic, 500 05
Olomouc, Czech Republic, 775 20
Ostrava, Czech Republic, 708 52
Praha 5, Czech Republic, 150 06
Rychnov nad Kneznou, Czech Republic, 516 01
Estonia
Tallinn, Estonia, 10617
Tartu, Estonia, EE-51014
Finland
Kuopio, Finland, FI-70210
Tampere, Finland, FI-33520
France
Lille, France, 59037
Montpellier, France, 34295
Ramonville Saint-Agne, France, 31520
Germany
Berlin, Germany, D-10365
Gottingen, Germany, 37075
Munchen, Germany, 80333
Ulm, Germany, 89081
Latvia
Riga, Latvia, LV-1002
Lithuania
Kaunas, Lithuania, LT-50009
Kaunas, Lithuania, LT-50185
Klaipeda, Lithuania, LT-92288
Siauliai, Lithuania, LT-76231
Vilnius, Lithuania, LT-03215
Vilnius, Lithuania, LT-08661
Netherlands
Rotterdam, Netherlands, 3012 KM
Spain
Valencia, Spain, 46009
Sweden
Stockholm, Sweden, 112 45
United Kingdom
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Eisai Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00368472    
Other Study ID Numbers: E2007-A001-207
First Posted: August 24, 2006    Key Record Dates
Results First Posted: December 10, 2015
Last Update Posted: December 10, 2015
Last Verified: November 2015
Keywords provided by Eisai Inc.:
Refractory
Partial
Seizures
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations