UMIN-CTR Clinical Trial

Basic information
Public title	The clinical trial to examine the densities of AMPA receptors in epilepsy patients with [11C]K-2
Acronym	The clinical trial to examine the densities of AMPA receptors in epilepsy patients with [11C]K-2
Scientific Title	The clinical trial to examine the densities of AMPA receptors in epilepsy patients with [11C]K-2
Scientific Title:Acronym	The clinical trial to examine the densities of AMPA receptors in epilepsy patients with [11C]K-2
Region	Japan

Condition
Condition	epilepsy
Classification by specialty	Neurology Psychiatry Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the differences in the distributions of [11C]K-2 and FDG between healthy subjects and epilepsy patients categorized by ILAE classification 2017
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To examine the differences in the distributions of AMPARs among the groups divided by seizure pattern in comparison with those of healthy subjects.
Key secondary outcomes	1. To examine the differences in the distributions of AMPARs between the groups divided by seizure pattern in comparison with their FDG-PET data. 2. To examine the correlation in the expected foci between those identified by AMPA-PET and EEG/MEG.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	The administration of PET tracer
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	1. Patients diagnosed with epilepsy on the basis of ILAE criteria 2. Patients who have seizures 12months prior to registration 3. Patients without neurosurgery in the past 4. Patients who are over 20 years and below 60 years 5. Patients who can consent to this study by oneself
Key exclusion criteria	1. Patients who have experienced the electric stimulation therapy 2. Patients who have severe renal dysfunction (Serum Cre>1.5) 3. Patients who have severe liver dysfunction (AST and ALT>150) 4. Patients who have severe cardiovascular disorder 5. Patients who have tatoo 6. Claustrophobic patients 7. Patients who can not agree with contraception during 7days after [11C]K-2 PET 8. Patients who take Perampanel or Topiramate(within 1month before this registration) 9.Patients who underwent nuclear medicine examination within 1 week before this registration 10.Patients who underwent other clinical trials using unapproved nuclear medicine examination within 6 months before this registration 11.Patients who underwent other clinical trial within 12 weeks before this registration 12.Patients whom study doctors consider inappropriate
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomoyuki Miyazaki
Organization	Yokohama City University, School of medicine
Division name	Department of Physiology
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2579
Email	johney@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Sayoko Nakashima
Organization	Yokohama City University hospital
Division name	YCU Center for Novel and Exploratory Clinical Trials
Zip code
Address	1-1-1 Fukuura,Kanazawa-ku,Yokohama,Japan
TEL	045-370-7994
Homepage URL
Email	sayoko_n@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University hospital
Institute
Department

Funding Source
Organization	Eisai Co., Ltd.
Organization
Division
Category of Funding Organization	Other
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	2018 Year 04 Month 01 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	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 10 Day
Date of IRB	2018 Year 02 Month 15 Day
Anticipated trial start date	2018 Year 08 Month 27 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 07 Day
Last modified on	2020 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036101