UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044131 |
|---|---|
| Receipt number | R000050392 |
| Scientific Title | An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study |
| Date of disclosure of the study information | 2021/05/23 |
| Last modified on | 2023/08/17 10:15:52 |
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Basic information
Public title
An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study
Acronym
An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study
Scientific Title
An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study
Scientific Title:Acronym
An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study
Region
| Japan |
Condition
Condition
Patients diagnosed with Focal Onset Seizures
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of perampanel as primary monotherapy with focal onset seizures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate 24-month seizure freedom in response
Key secondary outcomes
Secondary Objectives:
1. To evaluate the treatment effectiveness as measured by pragmatic seizure free rate in response to perampanel monotherapy at 6, 12, 18 and 30 months
2. To evaluate the treatment effectiveness as measured by sustained seizure freedom in response to perampanel monotherapy at 12 and 24 months
3. To evaluate 6, 12, 18, 24 and 30 months retention on perampanel
4. To evaluate the impact of perampanel monotherapy on the subject's quality of life (QOL) (i.e.EQ-5D-5L, VAS and PedsQL) from the baseline to the specific time points
5.To evaluate safety of perampanel monotherapy
Exploratory Objectives:
1. To explore the impact of perampanel monotherapy on sleep-related data from the baseline
2. To evaluate the treatment adherence of perampanel
3. To explore clinical factors that influence seizure freedom
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 4 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Male or female, age 4 years or older at the time of informed consent (in the case of minors, consent from a legal representative [eg, one parent] is required)
2) Diagnosed with FOS (with or without FBTCS) according to International League Against Epilepy (ILAE) 2017 classification
3) Newly diagnosed or recurrent epilepsy. For subjects with recurrent epilepsy, they must have relapsed at least 2 years after the end of the last antiepileptic drug (AED) treatment.
4) Subjects for whom the decision to initiate perampanel has been made, according to the judgment of the investigator
Key exclusion criteria
1) A history of receiving any AED (including AED used as rescue treatment) for more than 2 weeks in total within 2 years
2) Previously treated with perampanel at any time
3) A history of hypersensitivity to any of the excipients of perampanel
4) Severe hepatic impairment(Child-Pugh Score:C)
5) Subjects who have participated in a study involving administration of an investigational drug/biologics or device within 4 weeks
6) Not appropriate for the study according to the judgment of the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Akamatsu |
Organization
International University of Health and Welfare School of Medicine
Division name
Department of Neurology
Zip code
814-0001
Address
3-6-45, Momochihama, Sawara-ku, Fukuoka City 814-0001 FUKUOKA SANNO HOSPITAL
TEL
092-832-1100
akamatsu@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Sakaguchi |
Organization
Linical Co. ,Ltd.
Division name
Contract Medical Affairs Unit, Clinical Trial Operations
Zip code
105-0021
Address
1-9-2 Higashi-shimbashi, Minato-ku, Tokyo, 105-0021, Japan
TEL
03-6215-8005
Homepage URL
sakaguchi-tomoaki@linical.co.jp
Sponsor or person
Institute
International University of Health and Welfare and Eisai Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Linical Co. ,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
852 Hatakeda, Narita City, Chiba 286-8520
Tel
03-6215-8005
portable-study@linical.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国際医療福祉大学 成田病院（千葉県）、国立大学法人東京医科歯科大学病院（東京都）、医療法人社団ブレイン・コンシェルジュ おちあい脳クリニック（埼玉県）、東京女子医科大学附属足立医療センター（東京都）、市立伊丹病院（兵庫県）、東邦大学医療センター佐倉病院（千葉県）、医療法人社団武蔵野会 TMGあさか医療センター（埼玉県）、鹿児島大学病院（鹿児島県）、医療法人社団千紫会 新宿神経クリニック（東京都）、独立行政法人国立病院機構 長崎医療センター（長崎県）、医療法人 清照会 湊病院（青森県）、久留米大学病院（福岡県）、てんかんと発達の横浜みのる神経クリニック（神奈川県）、小出内科神経科（大阪府）、医療法人社団 高邦会 福岡山王病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study Design:An Open-label, Single arm, Multicenter, and Exploratory observational study
Recruitment method:Patients who start perampanel as monotherapy at our facility in May 2021 - June 2022.
Management information
Registered date
| 2021 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050392
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| Registered date | File name |
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| Registered date | File name |
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