NCT04870372

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

A Multi-center, Open-Label Study to Evaluate the Efficacy and Safety of Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-12-31
• Completion: 2021-04-30
• First posted: 2021-05-03
• Last updated: 2021-05-07

Locations

4 sites across 1 country: China