Status:
COMPLETED
Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
Lead Sponsor:
Second Affiliated Hospital of Soochow University
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.
Detailed Description
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline. Subjects who have a diagnosis of PD based on UK brain bank criteria with ESS\> 7 will be received Selegiline as an ad...
Eligibility Criteria
Inclusion
- Male or female and greater from 30 to 80.
- Diagnosis of idiopathic PD according to the UK Brain Bank criteria.
- Epworth Sleepiness Scale (ESS) \>7.
- Stable dose of anti-Parkinson drugs for at least 30 days.
- No use of MAO-B inhibitors within the preceding 4 weeks.
- No cognitive impairment, defined by Mini-Mental State Exam score ≤ 26.
Exclusion
- Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
- Shift-work, which cannot ensure a stable sleep-wake cycle habits.
- History of contraindications.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04870372
Start Date
March 1 2020
End Date
April 30 2021
Last Update
May 7 2021
Active Locations (4)
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1
Changshu Hospital Affiliated to Nanjing University of Chinese Medicine
Changshu, Jiangsu, China
2
Second Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
3
Department of Neurology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
4
Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine
Wuxi, Jiangsu, China