Lundbeck TOMs Orthostatic Hypotension

NCT ID: NCT04510922

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2020-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Droxidopa

100-600mg droxidopa TID

Group Type: EXPERIMENTAL

Droxidopa 100 MG [Northera]

Intervention Type: DRUG

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

Interventions

Droxidopa 100 MG [Northera]

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of idiopathic Parkinson's Disease, meeting UK Brain Bank criteria for at least 3 years
• Hoehn and Yahr (H&Y) stage I-III
• Age between 30 and 80 years old (both inclusive)
• Stable dosage of dopaminergic medications for at least 4 weeks
• Orthostatic Hypotension, defined as a fall in systolic BP ≥ 20 mmHg or diastolic BP ≥ 10 mmHg within 3 minutes of standing
• Willingness and ability to comply with scheduled visits

Exclusion Criteria

• Diabetes mellitus or other diseases potentially associated with autonomic dysfunction
• Treatment with antihypertensive drugs or with alpha-adrenergic antagonists
• Cognitive impairment, defined as a score < 24 at the Montreal Cognitive Assessment (MoCA)
• Any atypical signs lowering the diagnostic certainty for PD
• Lack of postural reflex defined as a score > 2 at the MDS-UPDRS item 3.12 (recover at the pull test)
• Severe levodopa induced dyskinesia, defined as an MDS-UPDRS item 4.2 > 2 (functional impact of dyskinesia)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lundbeck LLC

INDUSTRY

Sponsor Role: collaborator

Alberto Espay, MD, MSc

OTHER

Sponsor Role: lead

Responsible Party

Alberto Espay, MD, MSc

Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Lundbeck-TOMs-OH-001

Identifier Type: -

Identifier Source: org_study_id