Lundbeck TOMs Orthostatic Hypotension
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|ClinicalTrials.gov Identifier: NCT04510922|
Recruitment Status : Completed
First Posted : August 12, 2020
Results First Posted : September 26, 2022
Last Update Posted : September 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Orthostatic Hypotension Idiopathic Parkinson Disease||Drug: Droxidopa 100 MG [Northera]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study|
|Actual Study Start Date :||February 11, 2019|
|Actual Primary Completion Date :||December 31, 2020|
|Actual Study Completion Date :||December 31, 2020|
100-600mg droxidopa TID
Drug: Droxidopa 100 MG [Northera]
droxidopa taken three times a day titrated up to a maximum of 600 mg.
- Orthostatic Hypotension Questionnaire (OHQ) Score [ Time Frame: 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.
- Tinetti Score [ Time Frame: 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.
- PDQ-39 Score [ Time Frame: 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.
- Gait Analysis - Stride Length [ Time Frame: 1 month ]Measured in cm
- Gait Analysis - Single Leg Stance Time [ Time Frame: 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.
- Gait Analysis - Gait Velocity [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510922
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45219|