Extension Study of Ampreloxetine (TD-9855) for Treating snOH in Subjects With Primary Autonomic Failure
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04095793 |
Recruitment Status :
Recruiting
First Posted : September 19, 2019
Last Update Posted : October 17, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Symptomatic Neurogenic Orthostatic Hypotension | Drug: ampreloxetine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, 26-week, Open-Label, Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects With Primary Autonomic Failure |
Actual Study Start Date : | September 19, 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: ampreloxetine |
Drug: ampreloxetine
Oral tablet, QD
Other Name: TD-9855 |
- Physical examination [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Number of subjects with new abnormalities reported on their physical exam.
- Neurological Examination [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Number of subjects with new abnormalities reported on their neurological exam.
- Vital Signs [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Number of subjects with clinically significant vital sign abnormalities.
- ECGs [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Number of subjects with clinically significant ECG findings.
- Clinical Laboratory Tests [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Number of subjects with laboratory test abnormalities.
- Concomitant Medications [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Changes in concomitant medications
- Adverse Events (AEs) [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Incidence and severity of treatment-emergent adverse events
- Subject compliance to study treatment [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Number of subjects determined to be compliant with study medications.
- Incidence of Falls [ Time Frame: Baseline to Day 197 (over a 26 week period) ]Changes in incidence of falls
- Changes from baseline in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to Day 197 (over a 26 week period) ]The C-SSRS is a tool designed to systematically assess and track suicidal AEs (suicidal behavior and suicidal ideation) and will be used for all visits.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with ampreloxetine.
- The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
- The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of >4 in OHSA#1.
Exclusion Criteria:
- Subjects may not be enrolled in another clinical trial.
- Psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
- Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
- Hypersensitivity to ampreloxetine or the formulation excipients.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095793
Contact: Theravance Biopharma Call Center | 1-855-633-8479 | medinfo@theravance.com |
United States, Texas | |
University of Texas Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
United States, Washington | |
Inland Northwest Research | Recruiting |
Spokane, Washington, United States, 99202 |
Study Director: | Medical Monitor | Theravance Biopharma |
Responsible Party: | Theravance Biopharma |
ClinicalTrials.gov Identifier: | NCT04095793 History of Changes |
Other Study ID Numbers: |
0171 |
First Posted: | September 19, 2019 Key Record Dates |
Last Update Posted: | October 17, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ampreloxetine Symptomatic Neurogenic Orthostatic Hypotension snOH multiple symptom atrophy MSA Parkinson's disease PD pure autonomic failure PAF orthostatic hypotension |
OH 171 low blood pressure dizziness fainting blacking out lightheadedness norepinephrine hypotension OAK |
Hypotension, Orthostatic Pure Autonomic Failure Hypotension Vascular Diseases Cardiovascular Diseases |
Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |