Lundbeck TOMs Orthostatic Hypotension

Study Overview
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Brief Summary
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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.

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

Conditions
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Idiopathic Parkinson Disease, Orthostatic Hypotension

Intervention / Treatment
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* Drug: Droxidopa 100 MG [Northera]


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Droxidopa<br>100-600mg droxidopa TID | Drug: Droxidopa 100 MG [Northera]<br>* droxidopa taken three times a day titrated up to a maximum of 600 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic Hypotension Questionnaire (OHQ) Score | Orthostatic Hypotension Symptom Assessment (OHSA; Range: 0-10) and Orthostatic Hypotension Daily Activities Scale (OHDAS; Range: 0-10) 10 items measured on a Likert-scale with 10 being the worst possible score. | 1 month | 
| Tinetti Score | he Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's gait and balance abilities. Scoring: Items are scored either 0-1 or 0-2. 0 indicates the highest level of impairment, whereas a higher score (1 or 2) indicates the individuals independence. There were 17 tasks (one task split into two sub-items and scored twice) that the scores were summed for a highest possible score of 28 (10 items scored on a 0-1 scale, and 8 items scored on a 0-2 scale). The Tinetti assessment was compared pre- and post- 6 week medication dosing. | 6 weeks | 
| PDQ-39 Score | The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The scale consists of 39 items ranked on a 5-point ordinal scale (Never=0, Occasionally=1, Sometimes=2, Often=3, Always=4). Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better Quality of Life. Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100. Overall score = sum of dimension total scores divided by 8. Scores were compared pre- and post- 6 weeks dosing with medication. | 6 weeks | 
| Gait Analysis - Stride Length | Measured in cm | 1 month | 
| Gait Analysis - Single Leg Stance Time | Using a gait mat, participants were instructed to walk self-paced along the mat. The sensors in the mat automatically extracted the percentage of time a participant stood on a single leg. The output was compared pre- and post- 6 week dosing with study medication. | 6 weeks | 
| Gait Analysis - Gait Velocity | Using a gait mat, participants were instructed to walk self-paced on the mat, turn around, and walk back. Their velocity was measured in cm/sec. This output was compared pre- and post- 6 week dosing with study medication. | 6 weeks | 
| Postural Analysis - Postural Sway | Using a gait mat, postural sway was measured in cm on the X-axis while participants were asked to stand eyes open and eyes closed for 30 seconds. This output was compared pre- and post- 6 weeks dosing with study medication. | 6 weeks |