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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000036522 |
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Date of registration:
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16/04/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug
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Scientific title:
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Investigator-initiated clinical trial for progressive supranuclear palsy using an anti-cholinergic drug - Clinical trial for PSP using anticholinergic drug |
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Date of first enrolment:
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2019/04/15 |
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Target sample size:
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32 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041584 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Takayoshi
Shimohata |
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Address:
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1-1 Yanagido, Gifu
Japan |
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Telephone:
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058-230-6000 |
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Email:
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shimohata@gmail.com |
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Affiliation:
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Gifu University Graduate School of Medicine Department of Neurology |
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Name:
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Yuichi
Hayashi |
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Address:
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1-1 Yanagido, Gifu
501194
Japan |
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Telephone:
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0582306254 |
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Email:
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hayashiy@gifu-u.ac.jp |
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Affiliation:
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Gifu University Graduate School of Medicine Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
40years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Progressive supranuclear palsy
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Intervention(s)
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Trihexyphenidyl hydrochloride max.3mg for 3 months
Placebo max. 3mg for 3 months
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date: 03/04/2019
Contact:
rinri@gifu-u.ac.jp
Gifu University Graduate School of Medicine
058-230-6000
rinri@gifu-u.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2022 |
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URL:
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