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Lundbeck TOMs Orthostatic Hypotension

Primary Purpose

Orthostatic Hypotension, Idiopathic Parkinson Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Droxidopa 100 MG [Northera]
Sponsored by
Alberto Espay, MD, MSc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Orthostatic Hypotension

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Droxidopa

Arm Description

100-600mg droxidopa TID

Outcomes

Primary Outcome Measures

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.
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.
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.
Gait Analysis - Stride Length
Measured in cm
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2020
Last Updated
August 30, 2022
Sponsor
Alberto Espay, MD, MSc
Collaborators
Lundbeck LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04510922
Brief Title
Lundbeck TOMs Orthostatic Hypotension
Official Title
Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alberto Espay, MD, MSc
Collaborators
Lundbeck LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension, Idiopathic Parkinson Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Droxidopa
Arm Type
Experimental
Arm Description
100-600mg droxidopa TID
Intervention Type
Drug
Intervention Name(s)
Droxidopa 100 MG [Northera]
Intervention Description
droxidopa taken three times a day titrated up to a maximum of 600 mg.
Primary Outcome Measure Information:
Title
Orthostatic Hypotension Questionnaire (OHQ) Score
Description
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
Title
Tinetti Score
Description
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
Title
PDQ-39 Score
Description
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
Title
Gait Analysis - Stride Length
Description
Measured in cm
Time Frame
1 month
Title
Gait Analysis - Single Leg Stance Time
Description
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
Title
Gait Analysis - Gait Velocity
Description
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
Title
Postural Analysis - Postural Sway
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Lundbeck TOMs Orthostatic Hypotension

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