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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-UMIN000016734 |
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Date of registration:
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01/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The evaluation of duloxetine effect for the parkinsonism and gait freezing
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Scientific title:
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The evaluation of duloxetine effect for the parkinsonism and gait freezing - The evaluation of effect of duloxetine and parkinsonism |
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Date of first enrolment:
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2015/04/01 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019402 |
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Study type:
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Interventional |
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Study design:
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Single arm 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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Kenya Nishioka |
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Address:
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3-1-1 Hongo Bunkyo-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3813-3111 |
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Email:
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kenya.nishioka@gmail.com |
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Affiliation:
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Department of Neurology, Juntendo University School of Medicine Department of Neurology |
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Name:
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Kenya Nishioka |
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Address:
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3-1-1 Hongo Bunkyo-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3813-3111 |
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Email:
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kenya.nishioka@gmail.com |
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Affiliation:
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Department of Neurology, Juntendo University School of Medicine Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: The patinets adopted exclusion criteria 1, succidal tendency, severe depression. 2, Severe renal or liver dysfunction 3, hypoersensitivity for duloxetine. 4, Taking MAO-B inhibitor 5, complicated cognitive decline; MMSE under 23. 6, Schisophrenia or bipolar disorder 7, Personality disorders 8, eleavated ESR or CRP in blood examination. 9, ANA over 320 times, or Rheumatoid factor over 100 IU/ml. 10, comorbidity of epilepsy or seizure 11, dysuremia, galucoma. 12, alchol abuser 13, attending dcotor judge not to iclude this protocol.
Age minimum:
20years-old
Age maximum:
85years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Parkinson's disease
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Intervention(s)
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Drug ; Duloxetine Duraion; SEP012014-AUG312016 Doseage; 20mg/day or 40mg/day Times; one time per day P.O.
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Primary Outcome(s)
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FOG-Q:freezing of gait questionnair UPDRS:Unified Parkinson's Disease Rating Scale H & Y; Hoehn and Yahr stage HDR-S:Hamilton Depression Rating Scale Beck Score QIDS-J; Quick Inventory of Depressive Symptomatology HDS-R; revised Hasegawa's dementia scale MMSE; Mini-mental scale examination VAS; Visual Analog Scale FRS; Face rating scale WPI; Widespread pain index; from Fibromyalgia diagnostic criteria, ACR2010
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Source(s) of Monetary Support
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Department of Neurology, Juntendo University School of Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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