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

• Status: Completed
• Trial end date: 2021-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Soochow University
• Treatments: Selegiline

Criteria

Inclusion Criteria:

1. Male or female and greater from 30 to 80.

2. Diagnosis of idiopathic PD according to the UK Brain Bank criteria.

3. Epworth Sleepiness Scale (ESS) >7.

4. Stable dose of anti-Parkinson drugs for at least 30 days.

5. No use of MAO-B inhibitors within the preceding 4 weeks.

6. No cognitive impairment, defined by Mini-Mental State Exam score ≤ 26.

Exclusion Criteria:

1. Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.

2. Shift-work, which cannot ensure a stable sleep-wake cycle habits.

3. History of contraindications.