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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-04-30

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.

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Selegiline

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.

Group Type EXPERIMENTAL

Selegiline

Intervention Type 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.

Interventions

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Selegiline

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.

Intervention Type DRUG

Other Intervention Names

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ELDEPRYL

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No