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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/NCT01618695




Registration number
NCT01618695
Ethics application status
Date submitted
11/06/2012
Date registered
13/06/2012
Date last updated
29/07/2021

Titles & IDs
Public title
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Scientific title
A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Secondary ID [1] 0 0
E2007-J000-335
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partial-onset Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Perampanel
Treatment: Drugs - Placebo

Experimental: Perampanel -

Placebo Comparator: Placebo -


Treatment: Drugs: Perampanel
Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day.
Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day.

Treatment: Drugs: Placebo
Core study: Week 0 to Week 18 Once daily placebo.
Extension study:
Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)
Timepoint [1] 0 0
Baseline, Week 19
Secondary outcome [1] 0 0
Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)
Timepoint [1] 0 0
Baseline, Week 19
Secondary outcome [2] 0 0
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)
Timepoint [2] 0 0
Baseline, Week 19
Secondary outcome [3] 0 0
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores
Timepoint [3] 0 0
Baseline, Week 19

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Male or female and greater than or equal to 12 years of age;

2. Have a diagnosis of epilepsy with partial seizures with or without secondarily
generalized seizures

3. Participants with computed tomography (CT) or magnetic resonance imaging (MRI)
diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to
visit 1 that ruled out progressive central nervous system (CNS) disorders, example,
neurodegenerative disorders, brain tumors. For participants without existing CT or MRI
results, CT or MRI was performed at or after Visit 1 but results evaluation was
performed by Visit 2

4. Participants who had been treated for at least 12 weeks but confirmed to be
uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before
enrollment

5. During the 6-week Prerandomization Phase participants must have had greater than or
equal to 5 partial seizures per 6-week

6. Are currently being treated with stable doses and administrations of 1, 2, or a
maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or
oxcarbazepine only) out of the maximum of 3 AEDs is allowed
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Presence of nonmotor simple partial seizures only;

2. Presence of primary generalized epilepsies or seizures, such as absences and/or
myoclonic epilepsies;

3. Presence or previous history of Lennox-Gastaut syndrome;

4. A history of status epilepticus within 1 year prior to screening

5. Seizure clusters where individual seizures cannot be counted

6. A history of psychogenic seizures within 5 years prior to screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/05/2020
Sample size
Target
Accrual to date
Final
940
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Facility #1 - Bedford Park
Recruitment hospital [2] 0 0
Facility #1 - Camperdown
Recruitment hospital [3] 0 0
Facility #1 - Clayton
Recruitment hospital [4] 0 0
Facility #1 - Fitzroy
Recruitment hospital [5] 0 0
Facility #1 - Heidelberg
Recruitment hospital [6] 0 0
Facility #1 - Melbourne
Recruitment hospital [7] 0 0
Facility #1 - Randwick
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Fitzroy
Recruitment postcode(s) [5] 0 0
- Heidelberg
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Chongqing
Country [3] 0 0
China
State/province [3] 0 0
Fujian
Country [4] 0 0
China
State/province [4] 0 0
Guangdong
Country [5] 0 0
China
State/province [5] 0 0
Heilongjiang
Country [6] 0 0
China
State/province [6] 0 0
Jilin
Country [7] 0 0
China
State/province [7] 0 0
Shaanxi
Country [8] 0 0
China
State/province [8] 0 0
Shandong
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
China
State/province [10] 0 0
Shanxi
Country [11] 0 0
China
State/province [11] 0 0
Sichuan
Country [12] 0 0
China
State/province [12] 0 0
Tianjin
Country [13] 0 0
China
State/province [13] 0 0
Yunnan
Country [14] 0 0
China
State/province [14] 0 0
Zhejiang
Country [15] 0 0
Japan
State/province [15] 0 0
Aichi
Country [16] 0 0
Japan
State/province [16] 0 0
Ehime
Country [17] 0 0
Japan
State/province [17] 0 0
Fukui
Country [18] 0 0
Japan
State/province [18] 0 0
Fukuoka
Country [19] 0 0
Japan
State/province [19] 0 0
Hokkaido
Country [20] 0 0
Japan
State/province [20] 0 0
Hyogo
Country [21] 0 0
Japan
State/province [21] 0 0
Ibaraki
Country [22] 0 0
Japan
State/province [22] 0 0
Ishikawa
Country [23] 0 0
Japan
State/province [23] 0 0
Kagawa
Country [24] 0 0
Japan
State/province [24] 0 0
Kanagawa
Country [25] 0 0
Japan
State/province [25] 0 0
Kumamoto
Country [26] 0 0
Japan
State/province [26] 0 0
Miyagi
Country [27] 0 0
Japan
State/province [27] 0 0
Miyazaki
Country [28] 0 0
Japan
State/province [28] 0 0
Nagasaki
Country [29] 0 0
Japan
State/province [29] 0 0
Oita
Country [30] 0 0
Japan
State/province [30] 0 0
Okayama
Country [31] 0 0
Japan
State/province [31] 0 0
Osaka
Country [32] 0 0
Japan
State/province [32] 0 0
Saitama
Country [33] 0 0
Japan
State/province [33] 0 0
Shiga
Country [34] 0 0
Japan
State/province [34] 0 0
Shimane
Country [35] 0 0
Japan
State/province [35] 0 0
Shizuoka
Country [36] 0 0
Japan
State/province [36] 0 0
Tokushima
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Japan
State/province [38] 0 0
Yamaguchi
Country [39] 0 0
Japan
State/province [39] 0 0
Akita
Country [40] 0 0
Japan
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Aomori
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Japan
State/province [41] 0 0
Gifu
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Japan
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Hiroshima
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Japan
State/province [43] 0 0
Kagoshima
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Japan
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Kyoto
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Japan
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Nara
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Japan
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Niigata
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Japan
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Toyama
Country [48] 0 0
Japan
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Yamagata
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Korea, Republic of
State/province [49] 0 0
Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
Country [55] 0 0
Malaysia
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Kuala Lumpur
Country [56] 0 0
Malaysia
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Perak
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Malaysia
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Pulau Pinang
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Malaysia
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Terengganu
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Taiwan
State/province [59] 0 0
Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
Country [63] 0 0
Thailand
State/province [63] 0 0
Rajathevee
Country [64] 0 0
Thailand
State/province [64] 0 0
Tha Muang

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to confirm the efficacy and safety of perampanel compared to
placebo in patients with refractory partial-onset seizures
Trial website
https://clinicaltrials.gov/ct2/show/NCT01618695
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01618695