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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034612
Receipt No. 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 2020/04/27

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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
Email 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
Email amtateno@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039463

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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