Trial · NCT02705755
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
NCT02705755, Phase 2, Completed, Theravance Biopharma; results first posted 2022-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH). Trials, record NCT02705755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02705755
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
- NCT number
- NCT02705755
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Theravance Biopharma
- Conditions
Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Pure Autonomic Failure, Parkinson Disease, Hypotension, Orthostatic, Orthostatic Hypotension, Pure Autonomic Failure With Orthostatic Hypotension, Parkinson Disease With Orthostatic Hypotension
- Interventions
- TD-9855, Placebo
- First posted
- 2016-03-10
- Last updated
- 2022-09-26
- Results first posted
- 2022-09-26
- Limitations and caveats
- Part B of the study was discontinued in protocol amendment 2, however details regarding Part B are still included in this summary.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) | 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing) | Placebo referred to the Day 1 visit, and the change from placebo referred to the time-matched difference from each TD-9855 dosing day (Days 2 through 5) relative to placebo dosing (Day 1). |
| Primary | Part B: Change From Baseline in Seated SBP | Baseline and 7 hours post-dose on Day 1 | Baseline was defined as the pre-dose measurement on Day 1 of Part B. |
| Primary | Part C: Change From Baseline in Likert Scale Score at Week 4 | Baseline to Week 4 | The Likert Scale is question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA). The question asks participants to rate the severity of their orthostatic hypotension symptoms (dizziness, lightheadedness, feeling faint, or feeling like you might black out) on 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 higher score indicates a worse outcome. Baseline was defined as the pre-lunch measurement on Day -1. |
| Secondary | Part A and Part B: Change From Baseline in Likert Scale Score at 6 to 8 Hours | Baseline to a single time point between 6 to 8 hours post-dose | The Likert Scale is question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA). The question asks participants to rate the severity of their orthostatic hypotension symptoms (dizziness, lightheadedness, feeling faint, or feeling like you might black out) on 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 higher score indicates a worse outcome. Baseline was defined as the pre-dose measurement on Day 1 for Part A and Part B. Data was collected a one point between 6 and 8 hours post-dose. |
| Secondary | Part A and Part B: Change From Baseline in the Composite Orthostatic Hypotension Symptom Assessment (OHSA) Score | Baseline to a single time point between 6 to 8 hours post-dose | The OHSA is made up of a 6-item symptoms assessment. All items were scored on an 11-point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Activities that were marked as zero or "cannot be done for other reasons" at baseline were not included in the scoring. The composite OHSA score is the average of the response scores (for non-missing data) to the 6 questions of OHSA. A reduction in composite score indicates an improvement in symptoms. Baseline was defined as the pre-dose measurement on Day 1 for Part A and Part B. Data was collected a one point between 6 and 8 hours post-dose. |
| Secondary | Part A: Change From Time-matched Placebo in Standing SBP | 4 and 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing) | Placebo referred to the Day 1 visit, and the change from placebo referred to the time-matched difference from each TD-9855 dosing day (Days 2 through 5) relative to placebo dosing (Day 1). SBP was measured after 5 minutes of standing. |
| Secondary | Part B: Change From Baseline in Standing SBP | Baseline, 4 and 7 hours post-dose on Day 1 | SBP was measured after 3 minutes of standing. Baseline was defined as the pre-dose measurement on Day 1 of Part B. |
| Secondary | Part A: Change From Time-matched Placebo in Seated SBP | 4, 7, 9, 12 hours post-dose on Day 1 (placebo) and Days 2 to 5 (TD-9855 dosing) | Placebo referred to the Day 1 visit, and the change from placebo referred to the time-matched difference from each TD-9855 dosing day (Days 2 through 5) relative to placebo dosing (Day 1). |
| Secondary | Part B: Change From Baseline in Seated SBP | Baseline and 4, 7, 9 and 12 hours post-dose on Day 1 | Baseline was defined as the pre-dose measurement on Day 1 of Part B. |
| Secondary | Part A: Change From Time-matched Placebo in Duration of Standing During the Orthostatic Standing Test (OST) | 4 and 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing) | Blood pressure (BP) and heart rate (HR) measurements were recorded with automated (or manual) sphygmomanometer, after being seated for 5 min and 10 min, and after standing for 1, 3, 5, and 10 min. The standing time was measured with a chronometer and the duration of standing was recorded. The total duration of standing may have occurred between 2 of the predefined time points, or the participant may have been able to stand for longer than the 10-min standing test. In either case, the total duration was recorded. Placebo referred to the Day 1 visit, and the change from placebo referred to the time-matched difference from each TD-9855 dosing day (Days 2 through 5) relative to placebo dosing (Day 1) of Part A. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) | 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing) | Intent-to-treat (ITT) analysis set - All analyzable participants who received placebo on Day 1 of Part A. | millimeter of mercury (mmHg) | MEAN |
| PRIMARY | Part B: Change From Baseline in Seated SBP | Baseline and 7 hours post-dose on Day 1 | ITT analysis set - All analyzable participants who received any amount of placebo or TD-9855. | mmHg | MEAN |
| PRIMARY | Part C: Change From Baseline in Likert Scale Score at Week 4 | Baseline to Week 4 | ITT analysis set - All analyzable participants who received at least 1 dose of TD-9855. | score on a scale | MEAN |
| SECONDARY | Part A and Part B: Change From Baseline in Likert Scale Score at 6 to 8 Hours | Baseline to a single time point between 6 to 8 hours post-dose | ITT analysis set - All analyzable participants who received placebo on Day 1 of Part A. All analyzable participants who received any amount of placebo or TD-9855 in Part B. | score on a scale | MEAN |
| SECONDARY | Part A and Part B: Change From Baseline in the Composite Orthostatic Hypotension Symptom Assessment (OHSA) Score | Baseline to a single time point between 6 to 8 hours post-dose | ITT analysis set - All analyzable participants who received placebo on Day 1 of Part A. All analyzable participants who received any amount of placebo or TD-9855 in Part B. | score on a scale | MEAN |
| SECONDARY | Part A: Change From Time-matched Placebo in Standing SBP | 4 and 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing) | ITT analysis set - All analyzable participants who received placebo on Day 1 of Part A. | mmHg | MEAN |
| SECONDARY | Part B: Change From Baseline in Standing SBP | Baseline, 4 and 7 hours post-dose on Day 1 | ITT analysis set - All analyzable participants who received any amount of placebo or TD-9855. | mmHg | MEAN |
| SECONDARY | Part A: Change From Time-matched Placebo in Seated SBP | 4, 7, 9, 12 hours post-dose on Day 1 (placebo) and Days 2 to 5 (TD-9855 dosing) | ITT analysis set - All analyzable participants who received placebo on Day 1 of Part A. | mmHg | MEAN |
| SECONDARY | Part B: Change From Baseline in Seated SBP | Baseline and 4, 7, 9 and 12 hours post-dose on Day 1 | ITT analysis set - All analyzable participants who received any amount of placebo or TD-9855. | mmHg | MEAN |
| SECONDARY | Part A: Change From Time-matched Placebo in Duration of Standing During the Orthostatic Standing Test (OST) | 4 and 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing) | ITT analysis set - All analyzable participants who received placebo on Day 1 of Part A. | minutes | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) | Part A: TD-9855 1 mg | 0.2 | Standard Deviation 18.58 | millimeter of mercury (mmHg) | |
| Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) | Part A: TD-9855 2.5 mg | -1.8 | Standard Deviation 20.27 | millimeter of mercury (mmHg) | |
| Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) | Part A: TD-9855 5 mg | -3.4 | Standard Deviation 16.50 | millimeter of mercury (mmHg) | |
| Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) | Part A: TD-9855 10 mg | -2.9 | Standard Deviation 21.53 | millimeter of mercury (mmHg) | |
| Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) | Part A: TD-9855 20 mg | -7.3 | Standard Deviation 18.86 | millimeter of mercury (mmHg) | |
| Part B: Change From Baseline in Seated SBP | Part B: Randomized - Placebo | 0.30 | Standard Deviation 27.655 | mmHg | |
| Part B: Change From Baseline in Seated SBP | Part B: Randomized- TD-9855 | 9.00 | Standard Deviation 13.139 | mmHg | |
| Part C: Change From Baseline in Likert Scale Score at Week 4 | Part C: Dose Extension | -2.4 | Standard Deviation 4.54 | score on a scale | |
| Part A and Part B: Change From Baseline in Likert Scale Score at 6 to 8 Hours | Part A: Placebo | -0.6 | Standard Deviation 2.46 | score on a scale | |
| Part A and Part B: Change From Baseline in Likert Scale Score at 6 to 8 Hours | Part A: TD-9855 1 mg | -0.9 | Standard Deviation 4.08 | score on a scale |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow76
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (6 Days) | STARTED | Part A: Dose Escalation (Within Group) | 34 | |
| Part A (6 Days) | STARTED | Part B: Randomized - Placebo | 0 | |
| Part A (6 Days) | STARTED | Part B: Randomized- TD-9855 | 0 | |
| Part A (6 Days) | STARTED | Part C: Dose Extension | 0 | |
| Part A (6 Days) | Participants Who Received Placebo | Part A: Dose Escalation (Within Group) | 34 | |
| Part A (6 Days) | Participants Who Received Placebo | Part B: Randomized - Placebo | 0 | |
| Part A (6 Days) | Participants Who Received Placebo | Part B: Randomized- TD-9855 | 0 | |
| Part A (6 Days) | Participants Who Received Placebo | Part C: Dose Extension | 0 | |
| Part A (6 Days) | Participants Who Received 1 mg Study Drug | Part A: Dose Escalation (Within Group) | 17 | |
| Part A (6 Days) | Participants Who Received 1 mg Study Drug | Part B: Randomized - Placebo | 0 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 participant flowAdverse events549
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 | Atrial fibrillation | Cardiac disorders | Part A: Placebo | 0 | 34 | |
| other | Atrial fibrillation | Cardiac disorders | Part A: TD-9855 1 mg | 0 | 17 | |
| other | Atrial fibrillation | Cardiac disorders | Part A: TD-9855 2.5 mg | 0 | 31 | |
| other | Atrial fibrillation | Cardiac disorders | Part A: TD-9855 5 mg | 0 | 29 | |
| other | Atrial fibrillation | Cardiac disorders | Part A: TD-9855 10 mg | 1 | 28 | |
| other | Atrial fibrillation | Cardiac disorders | Part A: TD-9855 20 mg | 0 | 13 | |
| other | Atrial fibrillation | Cardiac disorders | Part B: Randomized - Placebo | 0 | 5 | |
| other | Atrial fibrillation | Cardiac disorders | Part B: Randomized - TD-9855 | 0 | 5 | |
| other | Atrial fibrillation | Cardiac disorders | Part C: Dose Extension | 0 | 21 | |
| other | Palpitations | Cardiac disorders | Part A: Placebo | 0 | 34 |
1 to 10 of 549Source ClinicalTrials.gov
See all 549 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Placebo | 0 | 34 |
| Total, all-cause mortality | Part A: TD-9855 1 mg | 0 | 17 |
| Total, all-cause mortality | Part A: TD-9855 2.5 mg | 0 | 31 |
| Total, all-cause mortality | Part A: TD-9855 5 mg | 0 | 29 |
| Total, all-cause mortality | Part A: TD-9855 10 mg | 0 | 28 |
| Total, all-cause mortality | Part A: TD-9855 20 mg | 0 | 13 |
| Total, all-cause mortality | Part B: Randomized - Placebo | 0 | 5 |
| Total, all-cause mortality | Part B: Randomized - TD-9855 | 0 | 5 |
| Total, all-cause mortality | Part C: Dose Extension | 0 | 21 |
| Total, other adverse events | Part A: Placebo | 7 | 34 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
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
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