Trial · NCT04510922
Lundbeck TOMs Orthostatic Hypotension
NCT04510922, Phase 4, Completed, Alberto Espay, MD, MSc; results first posted 2022-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lundbeck TOMs Orthostatic Hypotension. Trials, record NCT04510922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04510922
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lundbeck TOMs Orthostatic Hypotension
- NCT number
- NCT04510922
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 9 participants, actual
- Lead sponsor
- Alberto Espay, MD, MSc
- Conditions
- Orthostatic Hypotension, Idiopathic Parkinson Disease
- Interventions
- Droxidopa 100 MG [Northera]
- First posted
- 2020-08-12
- Last updated
- 2022-09-26
- Results first posted
- 2022-09-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | Gait Analysis - Stride Length | 1 month | Measured in cm |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Orthostatic Hypotension Questionnaire (OHQ) Score | 1 month | score on a scale | MEAN | |
| PRIMARY | Tinetti Score | 6 weeks | score on a scale | MEAN | |
| PRIMARY | PDQ-39 Score | 6 weeks | score on a scale | MEAN | |
| PRIMARY | Gait Analysis - Stride Length | 1 month | cm | MEAN | |
| PRIMARY | Gait Analysis - Single Leg Stance Time | 6 weeks | percentage of time | MEAN | |
| PRIMARY | Gait Analysis - Gait Velocity | 6 weeks | cm/sec | MEAN | |
| PRIMARY | Postural Analysis - Postural Sway | 6 weeks | cm | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Orthostatic Hypotension Questionnaire (OHQ) Score | Droxidopa | 4.6 | Standard Deviation 1.9 | score on a scale | |
| Tinetti Score | Droxidopa | 13.4 | Standard Deviation 2.07 | score on a scale | |
| PDQ-39 Score | Droxidopa | 31 | Standard Deviation 18.1 | score on a scale | |
| Gait Analysis - Stride Length | Droxidopa | 60.3 | Standard Deviation 9 | cm | |
| Gait Analysis - Single Leg Stance Time | Droxidopa | 34.6 | Standard Deviation 2 | percentage of time | |
| Gait Analysis - Gait Velocity | Droxidopa | 112.1 | Standard Deviation 17.2 | cm/sec | |
| Postural Analysis - Postural Sway | Droxidopa | 35.8 | Standard Deviation 51.2 | cm |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Droxidopa | 9 | |
| Overall Study | COMPLETED | Droxidopa | 9 | |
| Overall Study | NOT COMPLETED | Droxidopa | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Droxidopa | 0 | 9 |
| Total, other adverse events | Droxidopa | 0 | 9 |
| Total, serious adverse events | Droxidopa | 0 | 9 |
Source ClinicalTrials.gov
Papers21
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04510922
GET https://conductscience.org/api/trials/v1/NCT04510922/papers?page=2