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Extension Study of Ampreloxetine (TD-9855) for Treating snOH in Subjects With Primary Autonomic Failure (OAK)

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. Identifier: NCT04095793
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and snOH over 182 weeks.

Condition or disease Intervention/treatment Phase
Symptomatic Neurogenic Orthostatic Hypotension Drug: ampreloxetine Phase 3

Detailed Description:
This is a Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and snOH. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, 182-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 : February 2022
Estimated Study Completion Date : March 2025

Arm Intervention/treatment
Experimental: ampreloxetine
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
Drug: ampreloxetine
Oral tablet, QD
Other Name: TD-9855

Primary Outcome Measures :
  1. Physical examination [ Time Frame: Baseline to Week 26 ]
    Number of subjects with new abnormalities reported on their physical exam.

  2. Neurological Examination [ Time Frame: Baseline to Week 26 ]
    Number of subjects with new abnormalities reported on their neurological exam.

  3. Vital Signs [ Time Frame: Baseline to Week 26 ]
    Number of subjects with clinically significant vital sign abnormalities.

  4. ECGs [ Time Frame: Baseline to Week 26 ]
    Number of subjects with clinically significant ECG findings.

  5. Clinical Laboratory Tests [ Time Frame: Baseline to Week 26 ]
    Number of subjects with laboratory test abnormalities.

  6. Concomitant Medications [ Time Frame: Baseline to Week 26 ]
    Changes in concomitant medications

  7. Adverse Events (AEs) [ Time Frame: Baseline to Week 26 ]
    Incidence and severity of treatment-emergent adverse events

  8. Subject compliance to study treatment [ Time Frame: Baseline to Week 26 ]
    Number of subjects determined to be compliant with study medications.

  9. Incidence of Falls [ Time Frame: Baseline to Week 26 ]
    Changes in incidence of falls

  10. Changes from baseline in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to Week 26 ]
    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.

Information from the National Library of Medicine

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.

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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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04095793

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Contact: Theravance Biopharma Call Center 1-855-633-8479

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United States, Florida
Neurostudies, Inc. Recruiting
Port Charlotte, Florida, United States, 33952
United States, Illinois
NorthShore University HealthSystem Active, not recruiting
Glenview, Illinois, United States, 60026
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Minnesota
Mayo Clinic - Rochester Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
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
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Tartu University Hospital Active, not recruiting
Tartu, Estonia, 50406
Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K. Recruiting
Oswiecim, Poland, 32-600
Hospital del Mar Active, not recruiting
Barcelona, Spain, 8003
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine Recruiting
Kharkiv, Ukraine, 61172
Lviv Regional Clinical Hospital Recruiting
Lviv, Ukraine, 79010
United Kingdom
The National Hospital for Neurology & Neurosurgery Active, not recruiting
London, Greater London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
Theravance Biopharma
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Study Director: Medical Monitor Theravance Biopharma
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Responsible Party: Theravance Biopharma Identifier: NCT04095793    
Other Study ID Numbers: 0171
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theravance Biopharma:
Symptomatic Neurogenic Orthostatic Hypotension
multiple symptom atrophy
Parkinson's disease
pure autonomic failure
orthostatic hypotension
low blood pressure
blacking out
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Pure Autonomic Failure
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases