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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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13 December 2021 |
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Main ID: |
ChiCTR2100045946 |
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Date of registration:
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2021-04-30 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Improved Excessive Daytime Sleepiness with Selegiline in Parkinson’s Disease: An Open Trial
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Scientific title:
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Improved Excessive Daytime Sleepiness with Selegiline in Parkinson‘s Disease: An Open Trial |
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Date of first enrolment:
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2020-03-01 |
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Target sample size:
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Selegiline Group:140; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=125858 |
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Study type:
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Interventional study |
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Study design:
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Single arm
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Phase:
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4
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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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Zhang Jinru
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Address:
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1055 Sanxiang Road, Suzhou, Jiangsu, China
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Telephone:
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+86 15850210657 |
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Email:
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zhangjinruruby@126.com |
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Affiliation:
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The Second Affiliated Hospital of Soochow University |
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Name:
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Liu Chunfeng
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Address:
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1055 Sanxiang Road, Suzhou, Jiangsu, China
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Telephone:
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+86 512 67783307 |
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Email:
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liuchunfeng@suda.edu.cn |
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Affiliation:
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The Second Affiliated Hospital of Soochow University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male or female aged 30 to 80 years;
2. Diagnosis of idiopathic PD according to the UK Parkinson s Disease Society Brain Bank criteria;
3. Epworth Sleepiness Scale (ESS) > 7;
4. No cognitive impairment, defined by Mini-Mental State Exam score <= 26;
5. Stable dose of anti-Parkinson drugs for at least 30 days. No use of MAO-B inhibitors within the preceding 4 weeks;
6. Good compliance, able to independently complete the study evaluation.
Exclusion criteria: 1. Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism;
2. PD Patients with other neurological and/or psychiatric disorders;
3. Shift-work, which cannot ensure a stable sleep-wake cycle habits;
4. Participating in other PD intervention drugs or management programs;
5. Contraindications to selegiline.
Age minimum:
30
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Diseases
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Intervention(s)
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Selegiline Group:Selegiline;
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Primary Outcome(s)
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Epworth Sleepiness Scales;
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Secondary Outcome(s)
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Parkinson's Disease Sleepness Scales;Parkinson's Disease Patients Dairy Questionaires;
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Source(s) of Monetary Support
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Self-finance
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Ethics review
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Status: Approved
Approval date: 06/12/2019
Contact:
Hua Wenyan
+86 512 67783682
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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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