Trial · NCT03750552
Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
NCT03750552, Phase 3, Completed, Theravance Biopharma; results first posted 2022-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure. Trials, record NCT03750552. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03750552
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
- NCT number
- NCT03750552
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 195 participants, actual
- Lead sponsor
- Theravance Biopharma
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension
- Interventions
- ampreloxetine, Placebo
- First posted
- 2018-11-23
- Last updated
- 2022-09-14
- Other registries' IDs
- eudract:2018-003289-15
- Results first posted
- 2022-09-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4 | Baseline and Week 4 | OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome. |
| Secondary | Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score at Week 4 | Baseline and Week 4 | OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome. |
| Secondary | Change From Baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) Composite Score at Week 4 | Baseline and Week 4 | OHDAS is an assessment of how low blood pressure symptoms affect daily life. OHDAS is a 4 item assessment in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome. |
| Secondary | Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4 | Baseline and Week 4 | PGI-C was assessed using a 5-point scale where participants were asked to compare their current condition to their condition at baseline from 1 to 5, with 1 indicating the condition is very much improved and 5 indicating the condition is very much worse. These scores were analyzed in 2 categories: better and no change/worse. |
| Secondary | Number of Participants Who Experienced at Least One Fall | Up to Week 4 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4 | Baseline and Week 4 | Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, were included in this analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score at Week 4 | Baseline and Week 4 | Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, with a valid composite OHSA score at Week 4 were included in this analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) Composite Score at Week 4 | Baseline and Week 4 | Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, with a valid composite OHDAS score at Week 4 were included in this analysis. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4 | Baseline and Week 4 | Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, who have available data were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One Fall | Up to Week 4 | Participants included in the Full Analysis Set, defined as all randomized participants who received at least one dose of study medication and had at least 1 post-baseline measurement of Orthostatic Hypotension Symptom Assessment (OHSA) question 1, who have available data were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4 | Ampreloxetine | -1.69 | Standard Error 0.290 | score on a scale | |
| Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4 | Placebo | -1.45 | Standard Error 0.293 | score on a scale | |
| Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score at Week 4 | Ampreloxetine | -1.32 | Standard Error 0.200 | score on a scale | |
| Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score at Week 4 | Placebo | -1.05 | Standard Error 0.202 | score on a scale | |
| Change From Baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) Composite Score at Week 4 | Ampreloxetine | -1.22 | Standard Error 0.265 | score on a scale | |
| Change From Baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) Composite Score at Week 4 | Placebo | -0.95 | Standard Error 0.267 | score on a scale | |
| Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4 | Ampreloxetine | 49 | Participants | ||
| Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4 | Placebo | 45 | Participants | ||
| Number of Participants Who Experienced at Least One Fall | Ampreloxetine | 33 | Participants | ||
| Number of Participants Who Experienced at Least One Fall | Placebo | 22 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ampreloxetine | 98 | |
| Overall Study | STARTED | Placebo | 97 | |
| Overall Study | Safety Analysis Set | Ampreloxetine | 96 | |
| Overall Study | Safety Analysis Set | Placebo | 90 | |
| Overall Study | Full Analysis Set | Ampreloxetine | 94 | |
| Overall Study | Full Analysis Set | Placebo | 90 | |
| Overall Study | COMPLETED | Ampreloxetine | 90 | |
| Overall Study | COMPLETED | Placebo | 95 | |
| Overall Study | NOT COMPLETED | Ampreloxetine | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events212
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Ampreloxetine | 5 | 96 | |
| other | Headache | Nervous system disorders | Placebo | 3 | 90 | |
| other | Urinary tract infection | Infections and infestations | Ampreloxetine | 3 | 96 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 4 | 90 | |
| other | Fatigue | General disorders | Ampreloxetine | 3 | 96 | |
| other | Fatigue | General disorders | Placebo | 1 | 90 | |
| other | Insomnia | Psychiatric disorders | Ampreloxetine | 3 | 96 | |
| other | Insomnia | Psychiatric disorders | Placebo | 1 | 90 | |
| other | Nausea | Gastrointestinal disorders | Ampreloxetine | 2 | 96 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 90 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ampreloxetine | 0 | 96 |
| Total, all-cause mortality | Placebo | 0 | 90 |
| Total, other adverse events | Ampreloxetine | 42 | 96 |
| Total, other adverse events | Placebo | 38 | 90 |
| Total, serious adverse events | Ampreloxetine | 4 | 96 |
| Total, serious adverse events | Placebo | 2 | 90 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42475649 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ampreloxetine vs Placebo: Number of Participants Who Experienced at Least One Fall | Trial comparisons |
| Ampreloxetine vs Placebo: Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4 | Trial comparisons |
| Ampreloxetine vs Placebo: deaths from any cause | Trial comparisons |
| Ampreloxetine vs Placebo: serious adverse events | Trial comparisons |
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/NCT03750552
GET https://conductscience.org/api/trials/v1/NCT03750552/events?page=2