Lundbeck TOMs Orthostatic Hypotension

Alberto Espay, MD, MSc

Status and phase: Completed; Phase 4

Conditions: Idiopathic Parkinson Disease; Orthostatic Hypotension

Treatments: Drug: Droxidopa 100 MG [Northera]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04510922

Lundbeck-TOMs-OH-001

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Droxidopa

Experimental group

Description:

100-600mg droxidopa TID

Treatment:

Drug: Droxidopa 100 MG [Northera]