Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Open-Label Study to Evaluate the Efficacy and Safety of Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Selegiline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selegiline<br>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. | Drug: Selegiline<br>* 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.<br>* Other names: ELDEPRYL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |