Idiopathic Parkinson Disease, Orthostatic Hypotension
Conditions
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.
Interventions
DRUGDroxidopa 100 MG [Northera]
droxidopa taken three times a day titrated up to a maximum of 600 mg.
Sponsors
Lundbeck LLC
Alberto Espay, MD, MSc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Only 9 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Droxidopa 100-600mg droxidopa TID
Droxidopa 100 MG \[Northera\]: droxidopa taken three times a day titrated up to a maximum of 600 mg. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Droxidopa | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 3 Participants | — |
| Age, Continuous | 67.3 years STANDARD_DEVIATION 8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 9 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Droxidopa | Gait Analysis - Gait Velocity | 112.1 cm/sec | Standard Deviation 17.2 |
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Droxidopa | Gait Analysis - Single Leg Stance Time | 34.6 percentage of time | Standard Deviation 2 |
Primary
Gait Analysis - Stride Length
Measured in cm
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Droxidopa | Gait Analysis - Stride Length | 60.3 cm | Standard Deviation 9 |
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Droxidopa | Orthostatic Hypotension Questionnaire (OHQ) Score | 4.6 score on a scale | Standard Deviation 1.9 |
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Droxidopa | PDQ-39 Score | 31 score on a scale | Standard Deviation 18.1 |
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Droxidopa | Postural Analysis - Postural Sway | 35.8 cm | Standard Deviation 51.2 |
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Droxidopa | Tinetti Score | 13.4 score on a scale | Standard Deviation 2.07 |