UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031624 |
|---|---|
| Receipt number | R000036101 |
| Scientific Title | The clinical trial to examine the densities of AMPA receptors in epilepsy patients with [11C]K-2 |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/03/10 13:47:06 |
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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
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
sayoko_n@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036101
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| Registered date | File name |
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