UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of valproic acid in patients with postviral olfactory dysfunction
Acronym	Valproic acid treatment of olfactory dysfunction
Scientific Title	Efficacy and safety of valproic acid in patients with postviral olfactory dysfunction
Scientific Title:Acronym	Valproic acid treatment of olfactory dysfunction
Region	Japan

Condition
Condition	postviral olfactory dysfunction
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of valproic acid in patients with postviral olfactory dysfunction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase II

Assessment
Primary outcomes	changes of average recognition threshold scores measured by T and T olfactometer before and after treatment
Key secondary outcomes	changes of scores before and after treatment (visual analog scale and 5 grading scale of subjective symptoms, score measured by the odor stick identification test for Japanese, and average detection threshold scores measured by T and T olfactometer)

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	valproic acid Tab (200mg tablet), Sig: 1 tablet po BID for 24 weeks
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients are diagnosed to be a postviral olfactory dysfunction 2) Male patients of 20 or older and younger than 80 at the time of obtaining their consents, and Postmenopausal female patients younger than 65 3) Patients who understand the substances of this Trial and can consent in writing
Key exclusion criteria	Exclusion Criteria concerning Diagnosis 1)Patients taking Carbapenem,Barbituric acid,phenytoin, Carbamazepine, ethosuximide, amitriptyline, clobazam, lamotrigine, salicylic acid, Benzodiazepine, warfarin, erythromycin, cimetidine, clonazepam) 2) Patients having a history of serious drug allergies 3) Patients with severe depression, suicidal thinking or suicide attempt or past history of any of these diseases 4) Patients with liver dysfunction 5) Patients with renal dysfunction 6) Female patients having fertility 7) Patients with urea cycle abnormality 8) Patients with past history of an encephalopathy or a coma caused by unknown 9) Patients having a family member with urea cycle abnormality or who experience infant death 10) Patients with subjective olfactory loss before onset of postviral olfactory dysfunction 11) Patients who are otherwise judged unfit as a subject for this trial by a principal investigator or investigators participating in this trial
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Hirotaka Middle name Last name Kikuoka
Organization	Shiga university of Medical Science
Division name	otorhinolaryngology
Zip code	520-2153
Address	Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL	077-548-2261
Email	takao971@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Ogawa
Organization	Shiga university of Medical Science
Division name	otorhinolaryngology
Zip code	520-2153
Address	Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL	077-548-2261
Homepage URL
Email	takao971@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga university of Medical Science
Institute
Department

Funding Source
Organization	Department of otorhinolaryngology, Shiga university of Medical Science
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	shiga university of medical science
Address	Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
Tel	077-548-3576
Email	hqrec@belle.shiga-med.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	2016 Year 01 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	Completed
Date of protocol fixation	2015 Year 11 Month 26 Day
Date of IRB	2015 Year 10 Month 09 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 27 Day
Last modified on	2022 Year 05 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023047