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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-UMIN000024859 |
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Date of registration:
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16/11/2016 |
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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 effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.
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Scientific title:
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The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. - The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. |
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Date of first enrolment:
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2016/12/14 |
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Target sample size:
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50 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028608 |
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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 applicable
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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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Takashi
Abe |
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Address:
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6-6 Sakana-machi, Morioka-city,Iwate, Japan
Japan |
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Telephone:
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019-606-3711 |
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Email:
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ryuabe@crest.ocn.ne.jp |
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Affiliation:
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Medical Corporation Abe Neurology Clinic Neurology |
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Name:
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Keigo
Nakajima |
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Address:
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Acropolis TOKYO Bldg. 3F, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, Japan
162-0814
Japan |
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Telephone:
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03-5684-7809 |
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Email:
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TRF@eps.co.jp |
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Affiliation:
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EP-CRSU Co. Ltd. (Contract Research Organization) Clinical Research Headquarters |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)Patients who have taken zonisamide within 6 months from the start of study drug administration
2)Patients with cognitive impairment of MMSE score 23 or less
3)Patients who have undergone surgical therapy for parkinsonism, including stereotactic neurosurgery
4)Pregnant or possibly pregnant women, women of childbearing potential who do not agree to use appropriate contraceptive measures, or breast-feeding women
5)Patients who, in the opinion of the investigator or other study personnel, are unsuitable for the study
Age minimum:
30years-old
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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Switching from Dopamine agonist to Zonisamide.
Intervention period of 12 weeks.
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Primary Outcome(s)
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Change in the MDS-UPDRS Part III (motor symptoms) total score at 12 weeks and change in the MDS-UPDRS Part 1.2 (hallucinations and psychosis) score at 12 weeks
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Secondary Outcome(s)
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1)Change in the MDS-UPDRS Part1 (non-motor symptoms except Part 1.2) total score, change in the MDS-UPDRS Part 2(motor aspects) total score, and change in the MDS-UPDRS Part 4 (motor complications) total score
2)Change in the BDI-2(depression)total score
3)Change in the JESS(sleepiness)total score
4)Change in the J-ZBI(burden of caregiver) total score
5)Change in the NPI(BPSD) total score
6)Change in the MMSE(cognitive function)total score
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Source(s) of Monetary Support
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Sumitomo Dainippon Pharma Co., Ltd.
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Ethics review
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Status: YES
Approval date: 16/09/2016
Contact:
Fs-kubouchi@epsogo.co.jp
Joint Ethical Review Board
042-648-5551
Fs-kubouchi@epsogo.co.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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18/08/2018 |
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URL:
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