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

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ClinicalTrials.gov Identifier: NCT04095793
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : October 17, 2019
Sponsor:
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 26 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 2 periods: (i) 26-week treatment, and (ii) 2-week follow-up.

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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




Primary Outcome Measures :
  1. Physical examination [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with new abnormalities reported on their physical exam.

  2. Neurological Examination [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with new abnormalities reported on their neurological exam.

  3. Vital Signs [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with clinically significant vital sign abnormalities.

  4. ECGs [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with clinically significant ECG findings.

  5. Clinical Laboratory Tests [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with laboratory test abnormalities.

  6. Concomitant Medications [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Changes in concomitant medications

  7. Adverse Events (AEs) [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Incidence and severity of treatment-emergent adverse events

  8. 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.

  9. Incidence of Falls [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Changes in incidence of falls

  10. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Contacts
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Contact: Theravance Biopharma Call Center 1-855-633-8479 medinfo@theravance.com

Locations
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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
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma

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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.

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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:
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
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Pure Autonomic Failure
Hypotension
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases