UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036522 |
|---|---|
| Receipt number | 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 | 2020/04/15 12:07:30 |
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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
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
hayashiy@gifu-u.ac.jp
Sponsor or person
Institute
1) Department of Neurology, Gifu University Graduate School of Medicine,
2) National Hospital Organization, Higashi Nagoya Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041584
