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

Phase 4

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Selegiline

• Registration Number: NCT04870372
• Lead Sponsor: Second Affiliated Hospital of Soochow University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-15
• Study Start: 2020-03-01
• Primary Completion: 2020-12-31
• Study First Submitted QC: 2021-04-28
• Study Completion: 2021-04-30
• Status Verified: 2021-05
• Study First Posted: 2021-05-03
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Selegiline	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.

Primary Outcome Measures

Name	Time	Method
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.	8 weeks	This outcome was used to assess relationships among changes in ESS from baseline to the endpoint.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.	8 weeks	This outcome corresponds to the number of patients with daytime sleepiness.
The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.	8 weeks	This outcome reflects change of patients'daily quality.
The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.	8 weeks	This outcome corresponds to motor complications.

Trial Locations

Locations (4)

Second Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China

Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine; 🇨🇳 Wuxi, Jiangsu, China

Changshu Hospital Affiliated to Nanjing University of Chinese Medicine; 🇨🇳 Changshu, Jiangsu, China

Department of Neurology, Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China