UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and safety assessment of add-on therapy of perampanel for epilepsy patients
Title of the study (Brief title)	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	Shinichi Niijima
Organization	Juntendo University Nerima Hospital
Division name	Pediatrics Division
Address	3-1-10, Takanodai, Nerima-ku Tokyo, Japan
TEL	03-5923-3111
Email	sniijima@juntendo-nerima.jp

Public contact
Name of contact person	Noboru Yoshida
Organization	Juntendo University Nerima Hospital
Division name	Pediatrics Division
Address	3-1-10, Takanodai, Nerima-ku, Tokyo, Japan
TEL	03-5923-3111
Homepage URL
Email	noyoshi@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030838