UMIN-CTR Clinical Trial

Basic information
Public title	Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug
Acronym	Clinical trial for PSP using anticholinergic drug
Scientific Title	Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug
Scientific Title:Acronym	Clinical trial for PSP using anticholinergic drug
Region	Japan

Condition
Condition	Progressive supranuclear palsy
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of trihexyphenidyl hydrochloride for freezing symptoms (akinesia) due to progressive supranuclear palsy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of summation of scores 13-15, and 29-30 items of UPDRS and 2.12-2.13 items of MDS-UPDRS between pretreatment and 3 months after the treatment
Key secondary outcomes	Score of PSPRS, MMSE, FAB, MoCA, volume of voice, voice duration, timed up & go test, score of FOGQ, modified Schwab & England ADL scale, frequency of urination, and side effect

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Trihexyphenidyl hydrochloride max.3mg for 3 months
Interventions/Control_2	Placebo max. 3mg for 3 months
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)>=40 years old patient with progressive supranuclear palsy (PSP) when obtained informed consent 2) sporadic PSP 3) slowly progressive course 4)patient with freezing gait: the patients meet MDS-PSP criteria such as [probable PSP-RS(O1 or O2)+(P1 or P2), probable PSP-PGF (O1 or O2)+A1, possile PSP-RS (O2 +P3) or possible PSP-PGF A1] 5) severity of PSP 1-5 (except for 6) 6) >=15 points of MMSE score 7) existence of reliable care giver for the patient 8) researcher can obtain the written consent from the patient. Included a patient who meets the aobove mentioned all items.
Key exclusion criteria	1) attending other clinical trials 2) alcohol dependence or drug abuser 3) psychiatric disorder 4) allergy for anti-cholinergic drugs 5) severe liver or renal dysfunction 6) effective for levodopa, and/or using following drugs: anti-psychiatric agents, anti-epileptic drugs, acethycholine esterase inhibitor, memantine, immunosuppressant, corticosteroids, anti-coagulant, lithium, or anti-cholinergic drug 7) not suitable for clinical trial judged by principal investigator or researchers.
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Takayoshi Middle name Last name Shimohata
Organization	Gifu University Graduate School of Medicine
Division name	Department of Neurology
Zip code	5011194
Address	1-1 Yanagido, Gifu
TEL	058-230-6000
Email	shimohata@gmail.com

Public contact
Name of contact person	1st name Yuichi Middle name Last name Hayashi
Organization	Gifu University Graduate School of Medicine
Division name	Department of Neurology
Zip code	501194
Address	1-1 Yanagido, Gifu
TEL	0582306254
Homepage URL	http://www.med.gifu-u.ac.jp/neurology/research/psp.html
Email	hayashiy@gifu-u.ac.jp

Sponsor
Institute	1) Department of Neurology, Gifu University Graduate School of Medicine, 2) National Hospital Organization, Higashi Nagoya Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gifu University Graduate School of Medicine
Address	1-1 Yanagido, Gifu
Tel	058-230-6000
Email	rinri@gifu-u.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	岐阜大学医学部附属病院（岐阜県）/Gifu University Hospital 国立病院機構 東名古屋病院（愛知県）/National Hospital Organization Higashi Nagoya Hospital

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 16 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 03 Day
Date of IRB	2019 Year 04 Month 03 Day
Anticipated trial start date	2019 Year 04 Month 15 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 15 Day
Last modified on	2020 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041584