Lundbeck TOMs Orthostatic Hypotension

Phase 4

Completed

Conditions: Orthostatic Hypotension
Idiopathic Parkinson Disease

Interventions: Drug: Droxidopa 100 MG [Northera]

Registration Number: NCT04510922

Lead Sponsor: Alberto Espay, MD, MSc

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 9

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Droxidopa	Droxidopa 100 MG [Northera]	100-600mg droxidopa TID

Primary Outcome Measures

Name	Time	Method
Tinetti Score	6 weeks	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.
Gait Analysis - Gait Velocity	6 weeks	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.
Postural Analysis - Postural Sway	6 weeks	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.
Gait Analysis - Stride Length	1 month	Measured in cm
Gait Analysis - Single Leg Stance Time	6 weeks	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.
Orthostatic Hypotension Questionnaire (OHQ) Score	1 month	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.
PDQ-39 Score	6 weeks	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.