UMIN-CTR Clinical Trial

Basic information
Public title	Regional cerebral blood flow and metabolic changes associated with brain dysfunction induced by antihistamines
Acronym	Cerebral blood flow and metabolic changes associated with antihistamines
Scientific Title	Regional cerebral blood flow and metabolic changes associated with brain dysfunction induced by antihistamines
Scientific Title:Acronym	Cerebral blood flow and metabolic changes associated with antihistamines
Region	Japan

Condition
Condition	Allergy (Healthy volunteers)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	H1 antihistamines are often used in the medication for allergic diseases, coughs and colds, and insomnia, with or without prescription, even though their sedative properties are a potentially dangerous unwanted side effect that is not properly recognized. These sedative properties have been evaluated using the incidence of subjective sleepiness, objective cognitive and psychomotor functions in a cognitive study. This study is designed to evaluate the impairment in cognitive tasks after oral administration of levocetirizine 5 mg and diphenhydramine 50mg, as an active placebo, in healthy volunteers. In addition, regional cerebral blood flow and metabolism will be measured using near infrared spectroscopy (NIRS) and positron emission tomograhpy (PET).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	regional cerebral blood flow and metabolism in cognitive tests done after oral administration of levocetirizine 5 mg and diphenhydramine 50mg and placebo.
Key secondary outcomes	subjective sleepiness and performance in cognitive tests done after oral administration of levocetirizine 5 mg and diphenhydramine 50mg and placebo.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	levocetirizine 5mg
Interventions/Control_2	diphenhydramine 50mg
Interventions/Control_3	placebo
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	25 years-old >=
Gender	Male
Key inclusion criteria	1) Healthy volunteers (men; young subgroup ranging 20-25 years old) who understand the purpose of this study well. 2) Healthy volunteers with his/her own will and without any subordinate relation. 3) Subjects who can take enough sleep and rest during the night before the clinical test. 4) Subjects who can contact by mobile phones and who can participate 3 serial clinical tests.
Key exclusion criteria	Subjects with the following conditions are to be excluded: 1) Subjects who take medication acting on histaminergic nervous systems including antihistamines 2) Subjects with past history of severe epilepsy and allergic reactions 3) Subjects with past history of frequent hospitalization. 4) Subjects with moderate to severe glaucoma and uninary tract obstruction such as prostatic enlargement 5) Subjects with other disorders to which administration of anticholinergic and antihistaminergic treatment is not suitable 6) Subjects with moderate to severe abnormality in renal and liver functions 7) Subjects with moderate to severe cognitive impairment 8) Subjects with abnormality in brain MRI images. 9) other abnormalities, the investigators think the inclusion to this study is not suitable
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name TASHIRO
Organization	Tohoku University Cyclotron and Radioisotope Center/Tohoku University Graduate School of Medicine
Division name	Division of Cyclotron Nulclear Medicine (a branch clinic of Tohoku University Hospital)
Zip code	980-8578
Address	6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL	022-795-7797
Email	mtashiro@m.tohoku.ac.jp

Public contact
Name of contact person	1st name Manabu Middle name Last name TASHIRO
Organization	Tohoku University Cyclotron and Radioisotope Center
Division name	Division of Cyclotron Nulclear Medicine (a branch clinic of Tohoku University Hospital)
Zip code	980-8578
Address	6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL	022-795-7797
Homepage URL
Email	mtashiro@m.tohoku.ac.jp

Sponsor
Institute	Tohoku University Cyclotron and Radioisotope Center
Institute
Department

Funding Source
Organization	GSK Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tohoku University Graduate School of Medicine, Department of Pharmacology
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics comittee of Tohoku University Graduate School of Medicine
Address	1-1 Seiryo-cho Aoba-ku Sendai-shi Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	東北大学サイクロトロン・ラジオアイソトープセンター・サイクロトロン核医学（東北大学病院出張診療所）

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	42
Results	Healthy young Japanese men received single doses of levocetirizine or diphenhydramine. Subjective feeling, task performances, and brain activity were evaluated during cognitive tests. Regional cerebral glucose consumption changes and hemodynamic responses were measured using [18F]FDG-PET and NIRS, respectively. Energy consumption in the brain was significantly increased after antihistamine administration. Stroop test accuracy was significantly impaired by diphenhydramine.
Results date posted	2019 Year 04 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2018 Year 03 Month 13 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 16 Day
Date of IRB	2014 Year 10 Month 27 Day
Anticipated trial start date	2015 Year 03 Month 23 Day
Last follow-up date	2018 Year 12 Month 21 Day
Date of closure to data entry	2018 Year 12 Month 21 Day
Date trial data considered complete	2019 Year 03 Month 15 Day
Date analysis concluded	2019 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date	2015 Year 03 Month 23 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019283

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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