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Lundbeck TOMs Orthostatic Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04510922
Recruitment Status : Completed
First Posted : August 12, 2020
Results First Posted : September 26, 2022
Last Update Posted : September 26, 2022
Lundbeck LLC
Information provided by (Responsible Party):
Alberto Espay, MD, MSc, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Orthostatic Hypotension Idiopathic Parkinson Disease Drug: Droxidopa 100 MG [Northera] Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Droxidopa

Arm Intervention/treatment
Experimental: Droxidopa
100-600mg droxidopa TID
Drug: Droxidopa 100 MG [Northera]
droxidopa taken three times a day titrated up to a maximum of 600 mg.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Gait Analysis - Stride Length [ Time Frame: 1 month ]
    Measured in cm

  5. 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.

  6. 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.

  7. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

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

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Alberto Espay, MD, MSc
Lundbeck LLC
  Study Documents (Full-Text)

Documents provided by Alberto Espay, MD, MSc, University of Cincinnati:

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Responsible Party: Alberto Espay, MD, MSc, Professor of Neurology, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04510922    
Other Study ID Numbers: Lundbeck-TOMs-OH-001
First Posted: August 12, 2020    Key Record Dates
Results First Posted: September 26, 2022
Last Update Posted: September 26, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Parkinson Disease
Hypotension, Orthostatic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents