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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name