NCT03968744

Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease

A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Alain Kaelin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients suffering of Parkinson's Disease will be treated with 50 mg/day of Safinamide per os for 2 weeks (escalation phase). Then, safinamide will be increased up to 100 mg/day and, if tolerated, the treatment will be taken for 10 more weeks (maintenance phase). Total treatment 12 weeks.

Detailed description

Adult patients affected by PD and suffering from motor fluctuations will be screened for participation. If the inclusion and exclusion criteria are met, the participant will enter in the baseline assessment phase and undergo 1 night baseline PSG and 1 week baseline actigraphy. The patient will then start the treatment with 50 mg/day of Safinamide per os for 2 weeks (escalation phase). Then, safinamide will be increased up to 100 mg/day and, if tolerated, the treatment will last for 10 weeks (maintenance phase). At week 12 (end of treatment), the questionnaires, actigraphy and PSG will be repeated. A safety follow-up visit is scheduled 4 weeks after study treatment completion. The treatment will be continued thereafter in all patients if medically indicated.

Conditions

• Idiopathic Parkinson's Disease (at Later Stage)

Interventions

Type	Name	Description
DRUG	Safinamide	Safinamide taken per Os for 12 weeks

Timeline

• Start date: 2019-02-18
• Primary completion: 2026-02-02
• Completion: 2026-02-02
• First posted: 2019-05-30
• Last updated: 2026-03-13

Locations

1 site across 1 country: Switzerland