Trial · NCT03829657

Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

NCT03829657, Phase 3, Terminated, Theravance Biopharma; results first posted 2023-01-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure. Trials, record NCT03829657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03829657

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
NCT number: NCT03829657
Status: Terminated
Phases: Phase 3
Enrollment: 203 participants, actual
Lead sponsor: Theravance Biopharma
Conditions: Symptomatic Neurogenic Orthostatic Hypotension, MSA, Parkinson's Disease (PD), Pure Autonomic Failure (PAF)
Interventions: ampreloxetine, Placebo
First posted: 2019-02-04
Last updated: 2023-01-20
Other registries' IDs: eudract:2018-003941-41
Results first posted: 2023-01-20
Limitations and caveats: De Novo participants in the OL treatment period had limited follow-up due to early termination of the study.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period	6-week randomized withdrawal period (Week 16 to Week 22)	Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity. Least squares mean here is the model-based proportion of participants with treatment failure using logistic regression.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period	6-week randomized withdrawal period (Week 16 to Week 22)	RW Treatment Period Full Analysis Set: all randomized participants who received at least 1 dose of study medication (ampreloxetine or placebo) following randomization.	Proportion of participants	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period	RW Treatment Period: Placebo		0.42	Standard Error 0.068	Proportion of participants
Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period	RW Treatment Period: Ampreloxetine		0.30	Standard Error 0.065	Proportion of participants

Source ClinicalTrials.gov

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
OL Treatment Period (Week 1 to Week 16)	STARTED	OL Treatment Period: 0169 Placebo Rollover	85
OL Treatment Period (Week 1 to Week 16)	STARTED	OL Treatment Period: 0169 Ampreloxetine Rollover	85
OL Treatment Period (Week 1 to Week 16)	STARTED	OL Treatment Period: De Novo	33
OL Treatment Period (Week 1 to Week 16)	STARTED	RW Treatment Period: Placebo	0
OL Treatment Period (Week 1 to Week 16)	STARTED	RW Treatment Period: Ampreloxetine	0
OL Treatment Period (Week 1 to Week 16)	COMPLETED	OL Treatment Period: 0169 Placebo Rollover	52
OL Treatment Period (Week 1 to Week 16)	COMPLETED	OL Treatment Period: 0169 Ampreloxetine Rollover	64
OL Treatment Period (Week 1 to Week 16)	COMPLETED	OL Treatment Period: De Novo	12
OL Treatment Period (Week 1 to Week 16)	COMPLETED	RW Treatment Period: Placebo	0
OL Treatment Period (Week 1 to Week 16)	COMPLETED	RW Treatment Period: Ampreloxetine	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events935

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
other	Urinary tract infection	Infections and infestations	OL Treatment Period: 0169 Placebo Rollover	2	83
other	Urinary tract infection	Infections and infestations	OL Treatment Period: 0169 Ampreloxetine Rollover	8	85
other	Urinary tract infection	Infections and infestations	OL Treatment Period: De Novo	2	32
other	Urinary tract infection	Infections and infestations	RW Treatment Period: Placebo	3	64
other	Urinary tract infection	Infections and infestations	RW Treatment Period: Ampreloxetine	2	64
other	Headache	Nervous system disorders	OL Treatment Period: 0169 Placebo Rollover	5	83
other	Headache	Nervous system disorders	OL Treatment Period: 0169 Ampreloxetine Rollover	3	85
other	Headache	Nervous system disorders	OL Treatment Period: De Novo	0	32
other	Headache	Nervous system disorders	RW Treatment Period: Placebo	2	64
other	Headache	Nervous system disorders	RW Treatment Period: Ampreloxetine	0	64

1 to 10 of 935Source ClinicalTrials.gov

See all 935 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OL Treatment Period: 0169 Placebo Rollover	2	83
Total, all-cause mortality	OL Treatment Period: 0169 Ampreloxetine Rollover	3	85
Total, all-cause mortality	OL Treatment Period: De Novo	0	32
Total, all-cause mortality	RW Treatment Period: Placebo	0	64
Total, all-cause mortality	RW Treatment Period: Ampreloxetine	2	64
Total, other adverse events	OL Treatment Period: 0169 Placebo Rollover	41	83
Total, other adverse events	OL Treatment Period: 0169 Ampreloxetine Rollover	48	85
Total, other adverse events	OL Treatment Period: De Novo	16	32
Total, other adverse events	RW Treatment Period: Placebo	16	64
Total, other adverse events	RW Treatment Period: Ampreloxetine	17	64

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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