We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04095793
Recruitment Status : Terminated (Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.)
First Posted : September 19, 2019
Results First Posted : November 30, 2022
Last Update Posted : November 30, 2022
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 symptomatic nOH 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 symptomatic nOH. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 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, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure
Actual Study Start Date : September 19, 2019
Actual Primary Completion Date : November 12, 2021
Actual Study Completion Date : November 12, 2021

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. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to a maximum of 749 days ]

    An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period.

    Clinically significant abnormalities in physical and neurological examinations, vital signs, resting 12-lead electrocardiograms, and clinical laboratory evaluations, in addition to incidence of fall, suicidal ideation, and suicidal behavior, were reported as AEs.

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.

Layout table for eligibility information
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 ClinicalTrials.gov identifier (NCT number): NCT04095793

Show Show 55 study locations
Sponsors and Collaborators
Theravance Biopharma
Layout table for investigator information
Study Director: Medical Monitor Theravance Biopharma
  Study Documents (Full-Text)

Documents provided by Theravance Biopharma:
Study Protocol  [PDF] August 5, 2020
Statistical Analysis Plan  [PDF] January 13, 2022

Layout table for additonal information
Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT04095793    
Other Study ID Numbers: 0171
2019-002425-30 ( EudraCT Number )
First Posted: September 19, 2019    Key Record Dates
Results First Posted: November 30, 2022
Last Update Posted: November 30, 2022
Last Verified: November 2022
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.

Layout table for additional information
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
sympomatic nOH
multiple symptom atrophy
Parkinson's disease
pure autonomic failure
orthostatic hypotension
low blood pressure
blacking out
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension, Orthostatic
Pure Autonomic Failure
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases