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

Second Affiliated Hospital of Soochow University141 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Parkinson Disease

Interventions

SelegilineDRUG

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (4)

Changshu Hospital Affiliated to Nanjing University of Chinese Medicine

Changshu, Jiangsu, China

Second Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine

Wuxi, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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