NCT03944785

Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)

A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IV, prospective, observational, post-marketing study designed to obtain additional data on the effect of XADAGO on motor and non-motor symptoms in Parkinson's Disease patients newly prescribed XADAGO.

Detailed description

This Phase IV, multicenter, prospective, observational study to evaluate clinician-reported outcomes and patient-reported outcomes related to motor and non-motor symptoms, health status, quality of life and treatment satisfaction in PD patients who have been newly prescribed XADAGO according to Package Insert indication. This study also will gather "real world" data from a PD population in the US regarding their overall experience and degree of satisfaction with the use of XADAGO as an add-on treatment to their L-dopa regimen. Treatment experience will be captured using patient self-rating assessments as well as clinician ratings on assessments.

Conditions

• Idiopathic Parkinson Disease

Interventions

Type	Name	Description
DRUG	XADAGO (safinamide)	XADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.

Timeline

• Start date: 2017-11-30
• Primary completion: 2019-12-23
• Completion: 2020-01-10
• First posted: 2019-05-10
• Last updated: 2023-06-07
• Results posted: 2021-02-18

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study