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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-UMIN000010371 |
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Date of registration:
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01/04/2013 |
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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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Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease.
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Scientific title:
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Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease. - Study of zonisamide to tremor in patients with early Parkinson's disease. |
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Date of first enrolment:
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2013/04/08 |
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Target sample size:
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10 |
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Recruitment status: |
Pending |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012136 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-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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Yoshihisa Takiyama |
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Address:
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Shimokato 1110, Chuo, Yamanashi, Japan
Japan |
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Telephone:
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0552739896 |
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Email:
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mmiwa@yamanashi.ac.jp |
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Affiliation:
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University of Yamanashi Neurology |
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Name:
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Yoshihisa Takiyama |
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Address:
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Shimokato 1110, Chuo, Yamanashi, Japan
Japan |
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Telephone:
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055-273-9896 |
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Email:
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mmiwa@yamanashi.ac.jp |
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Affiliation:
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University of Yamanashi Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients with Parkinsonism other than Parkinson's disease 2) Patients who have taken zonisamide 3) Patients with dementia : [Mini Mental State Examination (MMSE) score is less than 22points 4) Patients with severs disease of heart, renal, liver, and other life-threatening diseases 5) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above
Age minimum:
Not applicable
Age maximum:
Not applicable
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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Start 25mg of Zonisamide and carry out observation 24weeks. Evaluate start point, after 4weeks, after 8weeks, after 16weeks, and after 24weeks.
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Primary Outcome(s)
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The change of tremor detected by actigraph
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Secondary Outcome(s)
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The change of UPDRS Part 2,3 The change of RBDSQ-J Adverse Events
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Source(s) of Monetary Support
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Department of Neurology, University of Yamanashi
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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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