Neurogenic Orthostatic HypotensionPhase 2NCT02705755
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
A Phase 2 study testing TD-9855 in people with Neurogenic Orthostatic Hypotension and Multiple System Atrophy (MSA) With Orthostatic Hypotension, run by Theravance Biopharma at 6 sites in United States.
Trial summary
This multiple-center, 3-part, single-blind dose escalation (Part A), randomized, double-blind (Part B), and open-label multiple dose extension (Part C) study will be conducted in male and female subjects with neurogenic orthostatic hypotension to evaluate the effect of TD-9855 in improving symptoms of orthostatic… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Pure Autonomic Failure
- What is being tested?
- TD-9855
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Sep 2017to 28 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, or pure autonomic failure, (i.e. neurogenic orthostatic hypotension).
- At screening, subject must meet the diagnostic criteria of neurogenic orthostatic hypotension, as demonstrated by a ≥ 30 mm Hg drop in systolic blood pressure (SBP) within 5 minutes of standing.
- Impaired autonomic reflexes, as determined by absence of BP overshoot during phase IV of the Valsalva maneuver, in subjects where Valsalva is performed, as appropriate.
- For the optional open-label extension study subjects must have demonstrated a pressor effect and completed dosing in Part A.
Who cannot join
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.
- Concomitant use of vasoconstricting agents for the purpose of increasing BP such as ephedrine, dihydroergotamine, or midodrine must be stopped at least 2 days or five half lives (whichever is longer) prior to dosing on Day 1 of Part A and C, and throughout the duration of Part C. Subjects previously enrolled in Part A under previous versions of the protocol will continue taking fludrocortisone during the washout period and in Part C at the dose and regimen used in Part A. For new subjects enrolling in Part A under Amendment 3, fludrocortisone use in both Parts of the study and during the washout period will be limited to 0.1 mg QD.
- Concomitant use of anti-hypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.
- Known or suspected alcohol or substance abuse within the past 12 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Theravance Biopharma Investigational Site
Berlin, New Jersey, 08009
Theravance Biopharma Investigational Site
Dallas, Texas, 75390
Theravance Biopharma Investigational Site
Farmington Hills, Michigan, 48334
Theravance Biopharma Investigational Site
Long Beach, California, 90806
Theravance Biopharma Investigational Site
Nashville, Tennessee, 37232
Theravance Biopharma Investigational Site
New York, New York, 10016
About this study
Official title: A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension
This multiple-center, 3-part, single-blind dose escalation (Part A), randomized, double-blind (Part B), and open-label multiple dose extension (Part C) study will be conducted in male and female subjects with neurogenic orthostatic hypotension to evaluate the effect of TD-9855 in improving symptoms of orthostatic intolerance.
Read the detailed description
Part A followed a daily, single-escalating-dose design, starting with placebo on Day 1, followed by a dose of 2.5 mg TD-9855 on Day 2, and proceeding to higher daily doses of TD-9855 up to a maximum dose of 20 mg based on safety, tolerability, and determination of a pressor effect.
The starting dose in Part A was initially set to 1 mg (Day 2), escalating to a maximum dose of 10 mg (Day 5), but this was revised to start at 2.5 mg (Day 2) and escalate to 20 mg (Day 5) in protocol amendment 2 (Section 9.8.1).
Part B followed a randomized, placebo-controlled, parallel design, evaluating an acute dose of TD-9855 that was determined to have a pressor effect and to be generally well tolerated for a given subject from Part A.
Subjects who completed Part A, demonstrated a pressor effect in Part A, and remained otherwise eligible, had the option to receive open-label TD-9855 by tablet daily for up to 5 months (20 weeks) during Part C.
- Conditions
- Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Pure Autonomic Failure, Parkinson Disease, Hypotension, Orthostatic, Orthostatic Hypotension
- Being tested
- TD-9855, Placebo
- Keywords
- Neurogenic Orthostatic Hypotension (nOH), Multiple System Atrophy (MSA), Pure Autonomic Failure, Parkinson Disease(PD), nOH, MSA, PD, PAF, Orthostatic Hypotension, ampreloxetine, TD-9855
- Medical subject headings
- Multiple system atrophy (MSA) with orthostatic hypotension, Pure Autonomic Failure, Parkinson Disease, Hypotension, Orthostatic, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD-9855Drug
Administered orally.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| TD-9855 Part A | Experimental | Subjects will receive placebo and escalating single doses of TD-9855 Receives: Drug: TD-9855; Drug: Placebo |
| TD-9855 Part B | Experimental | Subjects will receive a single dose of TD-9855 or placebo. Receives: Drug: TD-9855; Drug: Placebo |
| TD-9855 Part C | Experimental | Subjects will receive once daily doses of TD-9855 for up to 5 months as part of an optional outpatient open-label extension arm. Receives: Drug: TD-9855; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP)
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).
Measured: 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing)
Part B: Change From Baseline in Seated SBP
Baseline was defined as the pre-dose measurement on Day 1 of Part B.
Measured: Baseline and 7 hours post-dose on Day 1
Part C: Change From Baseline in Likert Scale Score at 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.
Measured: Baseline to Week 4
Secondary outcomes (15)
Part A and Part B: Change From Baseline in Likert Scale Score at 6 to 8 Hours
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.
Measured: Baseline to a single time point between 6 to 8 hours post-dose
Part A and Part B: Change From Baseline in the Composite Orthostatic Hypotension Symptom Assessment (OHSA) Score
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.
Measured: Baseline to a single time point between 6 to 8 hours post-dose
Part A: Change From Time-matched Placebo in Standing SBP
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.
Measured: 4 and 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing)
Part B: Change From Baseline in Standing SBP
SBP was measured after 3 minutes of standing. Baseline was defined as the pre-dose measurement on Day 1 of Part B.
Measured: Baseline, 4 and 7 hours post-dose on Day 1
Part A: Change From Time-matched Placebo in Seated SBP
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).
Measured: 4, 7, 9, 12 hours post-dose on Day 1 (placebo) and Days 2 to 5 (TD-9855 dosing)
Part B: Change From Baseline in Seated SBP
Baseline was defined as the pre-dose measurement on Day 1 of Part B.
Measured: Baseline and 4, 7, 9 and 12 hours post-dose on Day 1
Part A: Change From Time-matched Placebo in Duration of Standing During the Orthostatic Standing Test (OST)
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.
Measured: 4 and 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing)
Part B: Change From Baseline in Duration of Standing During the OST
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. Baseline was defined as the predose measurement on Day 1 of Part B.
Measured: Baseline and 7 hours post-dose on Day 1
Part C: Change From Baseline in the Composite OHSA Score
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, and the option of selecting "cannot be done for other reasons." 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. Baseline was defined as the pre-lunch measurement on Day -1.
Measured: Baseline to Day 169
Part C: Change From Baseline in the Orthostatic Hypotension Daily Activity Scale (OHDAS)
The OHDAS is made up of a 4-item daily activity 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, and the option of selecting "cannot be done for other reasons." Activities that were marked as zero or "cannot be done for other reasons" at baseline were not included in the scoring. The composite OHDAS score is the average of the response scores (for non-missing data) to the 4 questions of OHDAS. Baseline was defined as the pre-lunch measurement on Day -1.
Measured: Baseline to Day 169
Part C: Change From Baseline in the Orthostatic Hypotension Questionnaire (OHQ) Score
The OHQ is a 2-component questionnaire made up of 6-item symptoms assessment referred to as OHSA, and a 4-item daily activity assessment referred to as the OHDAS. 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, and the option of selecting "cannot be done for other reasons." 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. The composite OHDAS score is the average of the response scores (for non-missing data) to the 4 questions of OHDAS. The OHQ composite score is the average of the OHSA and OHDAS composite scores.
Baseline was defined as the pre-lunch measurement on Day -1.
Measured: Baseline to Day 169
Part C: Change From Baseline in Standing SBP
SBP was measured after 3 minutes of standing. Baseline was defined as the pre-lunch measurement on Day 1.
Measured: Baseline to Day 169
Part C: Change From Baseline in Seated SBP
Baseline was defined as the pre-breakfast measurement on Day 1.
Measured: Baseline to Day 169
Part C: Change From Baseline in Duration of Standing During the OST
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. Baseline was defined as the pre-breakfast measurement on Day 1.
Measured: Baseline to Day 169
Part C: Change From Baseline in Supine SBP to Seated SBP
Baseline is defined as pre-breakfast measurement on Day 1. The difference in SBP from a supine to a seated position was measured at baseline and at each time point. The change from baseline was calculated at each time point.
Measured: Baseline to Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start9 Sep 2017
- Primary completion24 Jul 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma, US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705755
- Sponsor's protocol ID
- 0145
- Status last verified
- Feb 2022
- First submitted
- 7 Mar 2016
- Last updated
- 26 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaufmann H, Vickery R, Wang W, Kanodia J, Shibao CA, Norcliffe-Kaufmann L, Haumann B, Biaggioni I. Safety and efficacy of ampreloxetine in symptomatic neurogenic orthostatic hypotension: a phase 2 trial. Clin Auton Res. 2021 Dec;31(6):699-711. doi: 10.1007/s10286-021-00827-0. Epub 2021 Oct 17.
PubMed 34657222Lo A, Norcliffe-Kaufmann L, Vickery R, Bourdet D, Kanodia J. Pharmacokinetics and pharmacodynamics of ampreloxetine, a novel, selective norepinephrine reuptake inhibitor, in symptomatic neurogenic orthostatic hypotension. Clin Auton Res. 2021 Jun;31(3):395-403. doi: 10.1007/s10286-021-00800-x. Epub 2021 Mar 29.
PubMed 33782836
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT02705755
- Acronym / sponsor ID
- 0145
- Conditions
- Neurogenic Orthostatic Hypotension, Multiple System Atrophy (MSA) With Orthostatic Hypotension, Pure Autonomic Failure, Parkinson Disease, Hypotension, Orthostatic, Orthostatic Hypotension
- Keywords
- Neurogenic Orthostatic Hypotension (nOH), Multiple System Atrophy (MSA), Pure Autonomic Failure, Parkinson Disease(PD), nOH, MSA, PD, PAF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Posted 26 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multiple-center, 3-part, single-blind dose escalation (Part A), randomized, double-blind (Part B), and open-label multiple dose extension (Part C) study will be conducted in male and female subjects with neurogenic orthostatic hypotension to evaluate the effect of TD-9855 in improving symptoms of orthostatic intolerance.
Detailed description
Part A followed a daily, single-escalating-dose design, starting with placebo on Day 1, followed by a dose of 2.5 mg TD-9855 on Day 2, and proceeding to higher daily doses of TD-9855 up to a maximum dose of 20 mg based on safety, tolerability, and determination of a pressor effect.
The starting dose in Part A was initially set to 1 mg (Day 2), escalating to a maximum dose of 10 mg (Day 5), but this was revised to start at 2.5 mg (Day 2) and escalate to 20 mg (Day 5) in protocol amendment 2 (Section 9.8.1).
Part B followed a randomized, placebo-controlled, parallel design, evaluating an acute dose of TD-9855 that was determined to have a pressor effect and to be generally well tolerated for a given subject from Part A.
Subjects who completed Part A, demonstrated a pressor effect in Part A, and remained otherwise eligible, had the option to receive open-label TD-9855 by tablet daily for up to 5 months (20 weeks) during Part C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TD-9855 Part A | Experimental | Drug: TD-9855, Drug: PlaceboSubjects will receive placebo and escalating single doses of TD-9855 |
| TD-9855 Part B | Experimental | Drug: TD-9855, Drug: PlaceboSubjects will receive a single dose of TD-9855 or placebo. |
| TD-9855 Part C | Experimental | Drug: TD-9855, Drug: PlaceboSubjects will receive once daily doses of TD-9855 for up to 5 months as part of an optional outpatient open-label extension arm. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, or pure autonomic failure, (i.e. neurogenic orthostatic hypotension).
- At screening, subject must meet the diagnostic criteria of neurogenic orthostatic hypotension, as demonstrated by a ≥ 30 mm Hg drop in systolic blood pressure (SBP) within 5 minutes of standing.
- Impaired autonomic reflexes, as determined by absence of BP overshoot during phase IV of the Valsalva maneuver, in subjects where Valsalva is performed, as appropriate.
- For the optional open-label extension study subjects must have demonstrated a pressor effect and completed dosing in Part A.
Key exclusion criteria (4 listed)
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.
- Concomitant use of vasoconstricting agents for the purpose of increasing BP such as ephedrine, dihydroergotamine, or midodrine must be stopped at least 2 days or five half lives (whichever is longer) prior to dosing on Day 1 of Part A and C, and throughout the duration of Part C. Subjects previously enrolled in Part A under previous versions of the protocol will continue taking fludrocortisone during the washout period and in Part C at the dose and regimen used in Part A. For new subjects enrolling in Part A under Amendment 3, fludrocortisone use in both Parts of the study and during the washout period will be limited to 0.1 mg QD.
- Concomitant use of anti-hypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.
- Known or suspected alcohol or substance abuse within the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD-9855Administered orally. | Drug | TD-9855 Part A, TD-9855 Part B, TD-9855 Part C |
| PlaceboAdministered orally. | Drug | TD-9855 Part A, TD-9855 Part B, TD-9855 Part C |
Primary outcome
Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP)
Time frame: 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).
Part B: Change From Baseline in Seated SBP
Time frame: Baseline and 7 hours post-dose on Day 1
Baseline was defined as the pre-dose measurement on Day 1 of Part B.
Part C: Change From Baseline in Likert Scale Score at Week 4
Time frame: 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.
15 secondary outcomes
Part A and Part B: Change From Baseline in Likert Scale Score at 6 to 8 Hours
Time frame: Baseline to a single time point between 6 to 8 hours post-dose
Part A and Part B: Change From Baseline in the Composite Orthostatic Hypotension Symptom Assessment (OHSA) Score
Time frame: Baseline to a single time point between 6 to 8 hours post-dose
Part A: Change From Time-matched Placebo in Standing SBP
Time frame: 4 and 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing)
Part B: Change From Baseline in Standing SBP
Time frame: Baseline, 4 and 7 hours post-dose on Day 1
Part A: Change From Time-matched Placebo in Seated SBP
Time frame: 4, 7, 9, 12 hours post-dose on Day 1 (placebo) and Days 2 to 5 (TD-9855 dosing)
Part B: Change From Baseline in Seated SBP
Time frame: Baseline and 4, 7, 9 and 12 hours post-dose on Day 1
Part A: Change From Time-matched Placebo in Duration of Standing During the Orthostatic Standing Test (OST)
Time frame: 4 and 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing)
Part B: Change From Baseline in Duration of Standing During the OST
Time frame: Baseline and 7 hours post-dose on Day 1
Part C: Change From Baseline in the Composite OHSA Score
Time frame: Baseline to Day 169
Part C: Change From Baseline in the Orthostatic Hypotension Daily Activity Scale (OHDAS)
Time frame: Baseline to Day 169
Part C: Change From Baseline in the Orthostatic Hypotension Questionnaire (OHQ) Score
Time frame: Baseline to Day 169
Part C: Change From Baseline in Standing SBP
Time frame: Baseline to Day 169
Part C: Change From Baseline in Seated SBP
Time frame: Baseline to Day 169
Part C: Change From Baseline in Duration of Standing During the OST
Time frame: Baseline to Day 169
Part C: Change From Baseline in Supine SBP to Seated SBP
Time frame: Baseline to Day 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34657222Kaufmann H, Vickery R, Wang W, Kanodia J, Shibao CA, Norcliffe-Kaufmann L, Haumann B, Biaggioni I. Safety and efficacy of ampreloxetine in symptomatic neurogenic orthostatic hypotension: a phase 2 trial. Clin Auton Res. 2021 Dec;31(6):699-711. doi: 10.1007/s10286-021-00827-0. Epub 2021 Oct 17.
- Derived from this study: PubMed 33782836Lo A, Norcliffe-Kaufmann L, Vickery R, Bourdet D, Kanodia J. Pharmacokinetics and pharmacodynamics of ampreloxetine, a novel, selective norepinephrine reuptake inhibitor, in symptomatic neurogenic orthostatic hypotension. Clin Auton Res. 2021 Jun;31(3):395-403. doi: 10.1007/s10286-021-00800-x. Epub 2021 Mar 29.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Orthostatic Hypotension
Active, not recruitingPhase 2
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Not yet recruiting
Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Not yet recruitingObservational study
Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study
Parkinson Disease (PD), REM Sleep Behavior Disorder (iRBD)
Recruiting
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
Orthostatic; Hypotension, Neurogenic, Autonomic Failure
RecruitingObservational study
Natural History Study of Synucleinopathies
Patients With Synucleinopathies, Neurogenic Orthostatic Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma, US, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TD-9855 in people with Neurogenic Orthostatic Hypotension and Multiple System Atrophy (MSA) With Orthostatic Hypotension, run by Theravance Biopharma at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Change From Time-matched Placebo in Seated Systolic Blood Pressure (SBP) (time frame: 7 hours post-dose on Day 1 (Placebo dosing) and on each of Days 2 to 5 (TD-9855 dosing)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02705755, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.