Lundbeck TOMs Orthostatic Hypotension

August 30, 2022 updated by: Alberto Espay, MD, MSc

Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
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.
6 weeks
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.
6 weeks
Gait Analysis - Stride Length
Time Frame: 1 month
Measured in cm
1 month
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 weeks
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberto Espay, MD, MSc

Collaborators

Lundbeck LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 11, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (ACTUAL)

August 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lundbeck-TOMs-OH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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