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

Soochow University

Status and phase: Completed; Phase 4

Conditions: Parkinson Disease

Treatments: Drug: Selegiline

Study type: Interventional

Funder types: Other

Identifiers

NCT04870372

JD-LK-2019-103-02

Details and patient eligibility

About

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

Full 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 adjunctive therapy or monotherapy. This study will assess the impact of Selegiline treatment on the severity of sleep disturbances among PD patients.

Enrollment: 141 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

Selegiline

Experimental group

Description:

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.

Treatment:

Drug: Selegiline