UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026880 |
|---|---|
| Receipt number | R000030838 |
| Scientific Title | Effectiveness and safety assessment of add-on therapy of perampanel for epilepsy patients |
| Date of disclosure of the study information | 2017/04/06 |
| Last modified on | 2018/10/07 23:15:33 |
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Basic information
Public title
Effectiveness and safety assessment of add-on therapy of perampanel for epilepsy patients
Acronym
Effectiveness and safety assessment of add-on therapy of perampanel for epilepsy patients
Scientific Title
Effectiveness and safety assessment of add-on therapy of perampanel for epilepsy patients
Scientific Title:Acronym
Effectiveness and safety assessment of add-on therapy of perampanel for epilepsy patients
Region
| Japan |
Condition
Condition
epilepsy syndromes
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Perampanel is an only one anti-epileptic drug that effects with AMPA receptors. It is required that evaluating of perampanel's effectiveness and safety for epilepsy patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Change of seizure frequency. The number of seizure attack every 2 weeks will be monitored.
Key secondary outcomes
A complete seizure reduction ratio, 50% reduction ratio, tolerability and EEG
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of perampanel
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as epilepsy syndrome with partial epilepsy
2. A patient treating with one anti-epileptic drug
Key exclusion criteria
1. Pregnancy patient
2. Simple partial seizure patient
3. Psychiatric unstable patient
4. Liver dysfunction patient
5. Alcoholic patient
6. Surgically treated patient
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Niijima |
Organization
Juntendo University Nerima Hospital
Division name
Pediatrics Division
Zip code
Address
3-1-10, Takanodai, Nerima-ku Tokyo, Japan
TEL
03-5923-3111
sniijima@juntendo-nerima.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Yoshida |
Organization
Juntendo University Nerima Hospital
Division name
Pediatrics Division
Zip code
Address
3-1-10, Takanodai, Nerima-ku, Tokyo, Japan
TEL
03-5923-3111
Homepage URL
noyoshi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 06 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2018 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030838
