UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036522
Receipt No. R000041584
Scientific Title Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug
Date of disclosure of the study information 2019/04/16
Last modified on 2019/04/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
2019 Year 04 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.