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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00368472
Registration number
NCT00368472
Ethics application status
Date submitted
22/08/2006
Date registered
24/08/2006
Date last updated
10/12/2015
Titles & IDs
Public title
4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
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Scientific 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
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Secondary ID [1]
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E2007-A001-207
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Perampanel
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
Treatment: Drugs: Perampanel
Perampanel 2 mg to 12 mg, once daily during the OLE study
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
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Assessment method [1]
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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.
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Timepoint [1]
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From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years
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Secondary outcome [1]
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Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Week 221
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Secondary outcome [2]
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Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to week 221
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2014
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Sample size
Target
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Accrual to date
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Final
138
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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- Chatswood
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Recruitment hospital [2]
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- Maroochydore
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Recruitment hospital [3]
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- Woodville
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Recruitment postcode(s) [1]
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2067 - Chatswood
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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5011 - Woodville
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Recruitment outside Australia
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United States of America
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Alabama
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Tielt
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Lille
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France
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Ramonville Saint-Agne
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Berlin
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Gottingen
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Munchen
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Germany
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Ulm
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Klaipeda
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Valencia
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Stockholm
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United Kingdom
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Dundee
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eisai Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00368472
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00368472
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