UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034612 |
|---|---|
| Receipt number | R000039463 |
| Scientific Title | Effects of dl-methylephedrine on dopamine transporter in healthy adulgs using PET: randomized, placebo-controlled, double-blind, comparative study |
| Date of disclosure of the study information | 2018/10/24 |
| Last modified on | 2021/04/26 09:10:11 |
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Basic information
Public title
Effects of dl-methylephedrine on dopamine transporter in healthy adulgs using PET: randomized, placebo-controlled, double-blind, comparative study
Acronym
methylephedrine DAT study
Scientific Title
Effects of dl-methylephedrine on dopamine transporter in healthy adulgs using PET: randomized, placebo-controlled, double-blind, comparative study
Scientific Title:Acronym
methylephedrine DAT study
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of dl-methylephedrine on the dopaminergic neuron system (dopamine transporter) using positron emission tomography.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
binding potential of dopamine transporter 2 hours after administration of dl-methylephedrine
Key secondary outcomes
blood and/or urine concentration, MRI
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
1) PET, MRI
2) single dose administration, dl-methylephedrine 60mg, PET
3) washout duration 1 week
4) single dose administration, placebo, PET
Interventions/Control_2
1) PET, MRI
2) single dose administration, placebo, PET
3) washout duration 1 week
4) single dose administration, dl-methylephedrine 60mg, PET
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Subjects with no history of psychiatric disorders.
Subjects with normal BMI (18.5-25).
Subjects without the history of smoking.
Subjects who have the ability to provide informed consent and adhere to the protocol.
Key exclusion criteria
Subjects with drug allergy.
Subjects taking drugs within 2 weeks of the trial.
Subjects with hyperthyroidism, hypertension, heart disease, diabetes, severe asthma or hypoxemia.
Subject who is contraindicated for the use of MRI.
Subject without the history of smoking.
Subject who are judged as not suitable for participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
+81-3-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | Amane |
| Middle name | |
| Last name | Tateno |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
+81-3-3822-2131
Homepage URL
amtateno@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Anti-Doping Agency
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
institutional review board of Nippon Medical School hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
Tel
+81-3-3822-2131
clinicaltrial@nms.ac.jp
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 | 10 | Month | 24 | Day |
Related information
URL releasing protocol
http://ctr-nms.com/
Publication of results
Partially published
Result
URL related to results and publications
https://www.playtruejapan.org/upload_files/governance/H30program_reportH31.3.31.pdf
Number of participants that the trial has enrolled
10
Results
There was no significant difference in the average change rate of DAT-BP between the two groups in both caudate (4.4% for methylephedrine group and -1.2% for placebo group) and putamen (3.6% for methylephedrine group and 0.5% for placebo group).
Results date posted
| 2020 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy volunteer
Participant flow
1. recruit
2. Quantification
3. 1st PET and other examination
4. Random allocation
5. 2nd PET and other examination
6. 3rd PET and other examination
Adverse events
None
Outcome measures
DAT-BP
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039463
