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This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.
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 adjunctive therapy or monotherapy. This study will assess the impact of Selegiline treatment on the severity of sleep disturbances among PD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selegiline | Experimental | Subjects who meet all of the inclusion and none of the exclusion criteria will be received Selegiline.The study medication dosage will be escalated from 5mg/daily to the target dose(5~10mg/daily) in 2 weeks and then maintained for the remaining 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selegiline | Drug | Subjects will receive one Selegiline tablet (5 mg) per day administered at breakfast. The initial dose of Selegiline is 5 mg/day and be up-titrated in 2-week intervals in increments of 5 mg up to 10 mg (which can be taken at breakfast or divided doses of 5 mg each taken at breakfast and lunch) according to the investigator's judgment, based on individual clinical response and tolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change of ESS score will be assessed from baseline to 8 weeks when given Selegiline as an adjunctive therapy or monotherapy in PD patients with daytime sleepiness. | This outcome was used to assess relationships among changes in ESS from baseline to the endpoint. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment. | This outcome corresponds to the number of patients with daytime sleepiness. | 8 weeks |
| The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun-feng Liu, MD,PhD | Second Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changshu Hospital Affiliated to Nanjing University of Chinese Medicine | Changshu | Jiangsu | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26085603 | Background | Tholfsen LK, Larsen JP, Schulz J, Tysnes OB, Gjerstad MD. Development of excessive daytime sleepiness in early Parkinson disease. Neurology. 2015 Jul 14;85(2):162-8. doi: 10.1212/WNL.0000000000001737. Epub 2015 Jun 17. | |
| 27827298 | Background | Panisset M, Stril JL, Belanger M, Lehoux G, Coffin D, Chouinard S. Open-Label Study of Sleep Disturbances in Patients with Parkinson's Disease Treated with Rasagiline. Can J Neurol Sci. 2016 Nov;43(6):809-814. doi: 10.1017/cjn.2016.289. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012642 | Selegiline |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
|
This outcome reflects change of patients'daily quality. |
| 8 weeks |
| The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment. | This outcome corresponds to motor complications. | 8 weeks |
| Second Affiliated Hospital of Nantong University |
| Nantong |
| Jiangsu |
| China |
| Department of Neurology, Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine | Wuxi | Jiangsu | China |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |