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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/NCT00735397
Registration number
NCT00735397
Ethics application status
Date submitted
13/08/2008
Date registered
14/08/2008
Date last updated
14/03/2016
Titles & IDs
Public title
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects 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 Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
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Secondary ID [1]
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E2007-G000-307
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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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0
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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0
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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 perampanel/placebo in the double blind-study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years.
Treatment: Drugs: perampanel
Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years
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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 with 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.
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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 5 years.
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Secondary outcome [1]
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Median 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 pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.
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Timepoint [1]
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Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)
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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. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.
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Timepoint [2]
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Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)
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Eligibility
Key inclusion criteria
Each participant who met the following criteria were enrolled in this study:
1. Who completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and
complied with the inclusion and exclusion criteria for that study (excluding criteria
that are related to seizure occurrences).
2. Provided written informed consent signed by participant or legal guardian prior to
entering the study or undergoing any study procedures (If the written informed consent
was provided by the legal guardian because the participant was unable to do so, a
written or verbal assent from the participant was obtained).
3. Who was considered reliable and willing to be available for the study period and
record seizures and report adverse events them self or have a caregiver who can record
and report the events for them.
4. Females who were either of non-childbearing potential (defined as having undergone
surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or
of childbearing potential. Females of childbearing potential were enrolled only if
they agreed to be abstinent or continue using at least 1 medically acceptable method
of contraception (eg, a double-barrier method [eg, condom + spermicide, condom +
diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the study
period and for 2 months after the last dose of study drug. Women using hormonal
contraceptives were required to use an additional approved method of contraception (as
described previously) continuously throughout the entire study period and for 2 months
after the last dose of study drug. (It was not required for male subjects to use
contraceptive measures based on preclinical toxicology data).
5. Continued to be treated with a stable dose of 1 or a maximum of 3 approved
anti-epileptic drugs.
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Minimum age
12
Years
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Maximum age
No limit
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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
Participants who met the following criteria were excluded from the study:
1. Those who, for any reason, discontinued early from the preceding double-blind study.
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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 3
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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
1/10/2008
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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
1/09/2014
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Sample size
Target
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Accrual to date
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Final
1218
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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- Woodville
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- Fitzroy
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- Heidelberg
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- Parkville
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5011 - Woodville
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3065 - Fitzroy
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3084 - Heidelberg
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3050 - Parkville
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Mexico
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Mexico City, Distrito Federal
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Mexico
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Monterrey, Nuevo Leon
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Mexico
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Poland
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Bialystok
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Gdansk
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Poland
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Katowice
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Lublin
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Warszawa
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Coimbra
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Portugal
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Porto
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Bucharest
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Omsk
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Russian Federation
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Samara
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Russian Federation
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Smolensk
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Russian Federation
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Tyumen
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Nis
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Serbia
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Novi Sad
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Madrid, Communidad de
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Goteborg
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Linkoping
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Taoyuan
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Chiangmai
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Thailand
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Muang
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Uzhgorod
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United Kingdom
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Middlesbrough
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United Kingdom
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Stoke-on-Trent
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Funding & Sponsors
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Commercial sector/Industry
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Name
Eisai Inc.
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Summary
Brief summary
The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12
mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to
evaluate the maintenance of effect of perampanel for the control of refractory partial
seizures.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00735397
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Contacts
Principal investigator
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Michelle Gee, PhD.
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Eisai Limited
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00735397
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