NCT04510922

Lundbeck TOMs Orthostatic Hypotension

Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Alberto Espay, MD, MSc · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Orthostatic hypotension (OH), which consists in a significant reduction in blood pressure levels upon standing from a seated position, may affect approximately one in three patients with Parkinson's disease (PD). It usually presents as dizziness, lightheadedness, feeling faint, or feeling like you might black out while standing. This can significantly impact the quality of life (QoL) of PD patients, resulting in difficulties with balance, walking, and increased risk of falls. The main aim of this study is to evaluate whether the use of technological devices (a computerized system for analyzing abnormalities in walking in clinical settings and a wearable sensor to detect changes in postural unsteadiness in the home environment) may improve the detection of complications and the response to medical therapies for OH in patients with PD.

Conditions

• Orthostatic Hypotension
• Idiopathic Parkinson Disease

Interventions

Type	Name	Description
DRUG	Droxidopa 100 MG [Northera]	droxidopa taken three times a day titrated up to a maximum of 600 mg.

Timeline

• Start date: 2019-02-11
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-08-12
• Last updated: 2022-09-26
• Results posted: 2022-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study