CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9 enrolled
Drug / intervention
Droxidopa 100 MG [Northera]drug
Likely dose
Droxidopa 100 MG [Northera]from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04510922
NCT04510922Phase 4Completed

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

Alberto Espay, MD, MSc·interventional·Posted Aug 12, 2020·Updated Sep 26, 2022

In Brief

A Phase 4 clinical trial evaluating Droxidopa 100 MG [Northera] for Orthostatic Hypotension and Idiopathic Parkinson Disease. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsLundbeck LLC

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 12, 2020
Enrollment StartFeb 11, 2019
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.9 years ago

Interventions

Droxidopa 100 MG [Northera]drug

droxidopa taken three times a day titrated up to a maximum of 600 mg.