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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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ChiCTR |
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Last refreshed on:
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23 April 2019 |
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Main ID: |
ChiCTR1900022534 |
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Date of registration:
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2019-04-15 |
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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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Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial
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Scientific title:
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Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial |
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Date of first enrolment:
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2019-06-01 |
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Target sample size:
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entacapone group:194;pramipexole group:194; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=38015 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Zheng Bei
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Address:
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Xinqiao Road, Gaodeng Street, Haikou
570100
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Telephone:
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+86 13876908681 |
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Email:
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zmjidf@163.com |
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Affiliation:
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Geriatric Hospital of Hainan |
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Name:
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Zheng Bei
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Address:
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Xinqiao Road, Gaodeng Street, Haikou
570100
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Telephone:
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+86 13876908681 |
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Email:
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zmjidf@163.com |
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Affiliation:
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Geriatric Hospital of Hainan |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1 Accordance with British Brain Bank Diagnostic Criteria for idiopathic Parkinson's Disease;
2 Record daily activities correctly;
3 Patient age 40 to 75 years, irrespective of sex;
4 Provision of written informed consent.
Exclusion criteria: 1 History of drug abuse;
2 Schizophrenia or severe cognitive impairment;
3 Epilepsy;
4 Severe metabolic dysfunction such as diabetes mellitus;
5 Malignant tumor;
6 Participation in other clinical trials.
Age minimum:
40
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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non-motor symptoms of Parkinson’s disease
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Intervention(s)
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entacapone group:Patients in the entacapone group will be administered entacapone (Novartis; import drug registration certificate number: H20160680), 10 times per day, 200 mg each time, for 3 weeks. ;pramipexole group:Patients in the pramipexole group will be administered pramipexole (Boehringer-Ingelheim; import drug registration certificate number: 20140918) , 3 times per day, 1 mg each time, for 3 weeks.;
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Primary Outcome(s)
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Improvement rate of non-motor symptoms;
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Secondary Outcome(s)
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Serum soluble interleukin-2 receptor levels;Serum homocysteine levels;Adverse events;
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Source(s) of Monetary Support
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Self-funded
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Ethics review
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Status: Approved
Approval date:
Contact:
Shuijing Jin
+86 0898-65875284
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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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