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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-UMIN000019676 |
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Date of registration:
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10/11/2015 |
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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 double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease
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Scientific title:
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The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease |
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Date of first enrolment:
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2015/11/10 |
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Target sample size:
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20 |
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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=R000022737 |
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Study type:
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Interventional |
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Study design:
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Cross-over 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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Rina
Ando |
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Address:
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Tohon, Ehime 791-0295, Japan
Japan |
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Telephone:
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089-960-5095 |
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Email:
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ando.rina.cn@ehime-u.ac.jp |
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Affiliation:
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Ehime University Graduate School of Medicine Neurology and Clinical Pharmacology |
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Name:
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Rina
Ando |
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Address:
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Tohon, Ehime 791-0295, Japan
791-0295
Japan |
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Telephone:
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089-960-5095 |
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Email:
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ando.rina.cn@ehime-u.ac.jp |
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Affiliation:
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Ehime University Graduate School of Medicine Neurology and Clinical Pharmacology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1 : Patient who can not take orally. 2 : Patient with severe arrhythmia. 3 : Pregnant women and lactating patient 4 : Patient can not answer a questionnaire about excessive daytime sleepiness. 5 : Patient can not make regular clinic visits. 6 : Patient have methylphenidate or/and Pemoline. 7 : Patient is difficult to express one's agreement.
Age minimum:
20years-old
Age maximum:
100years-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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taking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks
taking matching placebo after breakfast for 4 weeks, wash out for 2 weeks, taking modafinil (200 mg/day) after breakfast for 4 weeks
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Primary Outcome(s)
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change of the Epworth Sleepiness Scale score
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Secondary Outcome(s)
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change of UPDRS part2 and 3 score, Mini Mental State Examination score, basic rhythm of brain waves and evaluation of caregivers
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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: 27/07/2015
Contact:
rinri@m.ehime-u.ac.jp
Institutional Review Board ,Ehime University Hospital
089-960-5914
rinri@m.ehime-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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25/03/2019 |
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Date Completed:
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31/03/2019 |
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URL:
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