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Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (SEQUOIA)

Primary Purpose

Symptomatic Neurogenic Orthostatic Hypotension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ampreloxetine
Placebo
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Neurogenic Orthostatic Hypotension focused on measuring Symptomatic Neurogenic Orthostatic Hypotension, symptomatic nOH, multiple system atrophy, MSA, Parkinson's disease, PD, pure autonomic failure, PAF, primary autonomic failure, SEQUOIA, ampreloxetine, low blood pressure, dizziness, fainting, blacking out, lightheadedness, norepinephrine, hypotension, Parkinsonism, TD-9855, Neurogenic Orthostatic Hypotension, nOH, 0145, 145, 169, 0169, TD9855

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is male or female and at least 30 years old.
  • Subject must meet the diagnostic criteria of symptomatic nOH, as demonstrated by a sustained reduction in BP of ≥20 mm Hg (systolic) or ≥10 mm Hg (diastolic) within 3 minutes of being tilted-up to ≥60o from a supine position as determined by a tilt-table test.
  • Subject must score at least a 4 on the Orthostatic Hypotension Symptom Assessment Question #1 at randomization visit.
  • For subjects with PD only: Subject has a diagnosis of PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992).
  • For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008).
  • For subjects with PAF only: Subject has documented impaired autonomic reflexes, including the Valsalva maneuver performed within 24 months from the date of randomization.
  • Subject has plasma NE levels >100 pg/mL after being in seated position for 30 minutes.

Exclusion Criteria:

  • Subject has a known systemic illness known to produce autonomic neuropathy, including but not limited to amyloidosis, and autoimmune neuropathies.
  • Subject has a known intolerance to other NRIs or SNRIs.
  • Subject currently uses concomitant antihypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.
  • Subject has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives, whichever is longer, prior to randomization or requires concomitant use until the follow-up visit.

  • Subject has changed dose, frequency, or type of prescribed medication for orthostatic hypotension within 7 days prior to V1.

    • Midodrine and droxidopa (if applicable) must be tapered off at least 7 days prior to V1.
  • Subject has a known or suspected alcohol or substance abuse within the past 12 months (DSM-IV-TR® definition of alcohol or substance abuse).
  • Subject has a clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months.
  • Subject has used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to randomization.
  • Subject has a history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the subject.
  • Subject has any significant uncontrolled cardiac arrhythmia.
  • Subject has a Montreal Cognitive Assessment (MoCA) ≤23.
  • Subject had a myocardial infarction in the past 6 months or has current unstable angina.
  • Subject has known congestive heart failure (New York Heart Association [NYHA] Class 3 or 4).
  • Subject has a clinically significant abnormal laboratory findings (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3.0 x upper limit of normal [ULN]; blood bilirubin [total] >1.5 x ULN; estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or any abnormal laboratory value that could interfere with safety of the subject).
  • Subject has demonstrated a history of lifetime suicidal ideation and/or suicidal behavior, as outlined by the C-SSRS (Columbia Suicide Severity Rating Scale) (Baseline/Screening Version) subject should be assessed by the rater for risk of suicide and the subject's appropriateness for inclusion in the study.

Sites / Locations

  • Banner Sun Health Research Institute
  • Collaborative Neuroscience Network, LLC
  • Stanford Neuroscience Health Center
  • Colorado Springs Neurological Associates, PC
  • University of Colorado Health
  • Georgetown University Hospital, Dept. of Neurology
  • Parkinson's Disease and Movement Disorders Center
  • SFM Clinical Research
  • Fixel Institute for Neurological Diseases
  • Neurostudies, Inc
  • Rush University Medical Center
  • NorthShore University Health System
  • University of Kansas Medical Center
  • Mayo Clinic - Rochester
  • Rutgers New Jersey Medical School
  • New York University Langone Health
  • University of Cincinnati Medical Center
  • The Ohio State University Wexner Medical Center
  • Oregon Health & Science University
  • Vanderbilt University Medical Center
  • University of Texas Southwestern Medical Center
  • Georgetown University Hospital
  • Inland Northwest Research
  • Concord Hospital
  • Royal Brisbane and Women's Hospital
  • Monash Health - Clinical Trials Centre
  • The Royal Melbourne Hospital
  • Perron Institute for Neurological and Translational Science, QEII Medical Centre
  • Medizinische Universitat Innsbruck Abteilung Fur Neurologie
  • Universitätsklinikum Tulln
  • Wilhelminenspital Wien Abteilung fur Neurologie
  • UMHAT Sveti Georgi EAD Clinic of Neurological Diseases
  • MHATNP Sv.Naum, EAD
  • UMHAT Alexandrovska EAD Clinic of Neurological Diseases
  • University of Calgary
  • London Health Sciences Centre-CCIT
  • University Health Network - Toronto Western Hospital Movement Disorders Clinic
  • Montreal Neurological Institute and Hospital
  • Bispebjerg og Frederiksberg Hospital
  • Odense Universitetshospital
  • East Tallinn Central Hospital
  • Astra Team Clinic
  • Tartu University Hospital
  • Hopital Roger Salengro - CHU Lille
  • CHU Caremeau
  • Hospital Pierre Paul Rquet, CHU Purpan
  • Universitaetsklinikum Freiburg - Klinik fur Neurologie und Neurophysiologie
  • Gemeinschaftspraxis Dr. med. J. Springub/ W. Schwarz
  • Praxis Dr. Oehlwein
  • Charite Universitatsmedizin Berlin - Campus Benjamin Franklin
  • Alexianer St. Joseph-Krankenhaus Berlin-Weißensee, Klinik für Neurologie
  • Charite - Campus Virchow-Klinikum, Klinik fur Neurologie
  • Charite - Campus Virchow-Klinikum
  • Clinexpert Kft.
  • Semmelweis Egyetem
  • Pecsi Tudomanyegyetem, Neurologiai Klinika
  • Szent Borbala Korhaz
  • Rabin Medical Center
  • Kaplan Medical Center
  • Ziv Medical Center
  • Tel Aviv Medical Center
  • Chaim Sheba Medical Center
  • Istituto Clinico Humanitas - IRCCS
  • Fondazione Istituto G.Giglio di Cefalù
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Umberto I - G.M. Lancisi - G. Salesi, SOD Clinica di Neuroriabilitazione
  • Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
  • Azienda Ospedaliero - Universitaria Policlinico Vittorio Emanuele. - P.O G. Rodolico, Clinica Neurologica
  • Universita Gabriele D'Annunzio- Cesi-Met
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  • Ospedale San Raffaele I U.O. di Neurologia
  • Azienda Ospedaliero Universitaria Pisana
  • Fondazione PTV - Policlinico Tor Vergata I U.O.C. Neurologia
  • Ospedale San Giovanni Battista del Sovrano Militare Ordine di Malta
  • Ospedale San Giovanni Battista
  • Policlinico Umberto I - Universita degli Studi di Roma La Sapienza / Neurologia
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
  • Sapienza University of Rome
  • AOU San Giovanni di Dio e Ruggi d'Aragona
  • A.O. Santa Maria
  • New Zealand Brain Research Institute
  • Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
  • PRATIA MCM Kraków
  • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Instytut Zdrowia dr Boczarska-Jedynak
  • NEURO-CARE Sp. z o.o. Sp. Komandytowa
  • ETG Warszawa
  • Specjalistyczne Gabinety sp. z o.o.
  • Hospital Senhora da Oliveira - Guimaraes, EPE
  • Centro Hospitalar e Universitario Lisboa Norte - Hospital de Santa Maria
  • Campus Neurologico Senior
  • State Autonomous Institution of Healthcare Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
  • Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
  • Federal State Budgetary Educational Institution of Additional Professional Education Russian Medical Academy of Continuous Postgraduate Education of the Ministry of Healthcare of the Russian Federation
  • NHI Central Clinical Hospital #2 of JSC Russian Railways N.A. Semashko
  • City Neurological Center Sibneiromed
  • SBEIHPE Novosibirsk State Medical University
  • Federal State Budgetary Institution National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the Ministry of Healthcare of the Russian Federation
  • Human Brain Institute RAMS
  • Saint Petersburg State Budgetary Institution of Healthcare City Hospital # 40 of Kurortnyi Region
  • Regional State Budgetary Institution of Healthcare Smolensk Regional Clinical Hospital
  • Hospital Universitario Donostia
  • Complejo Hospitalario de Navarra
  • Navarrabiomed Fundacion Miguel Servet
  • Hospital de Cruces
  • Hospital del Mar
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Mutua de Terrasa
  • Hospital Universitario Puerta del Mar
  • Hospital Universitario de La Princesa
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Virgen del Rocio
  • Communal Institution Dnipropetrovsk I.I.Mechnikov RCH
  • Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council
  • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Dept of Neurology
  • CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
  • Communal Institution City Clinical Hospital #6
  • Royal Devon and Exeter Hospital
  • Re:Cognition Health
  • Barts Hospital
  • The National Hospital for Neurology & Neurosurgery
  • King's College Hospital
  • Re:Cognition Health Ltd
  • Re:Cognition Health
  • Salford Royal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ampreloxetine

Placebo

Arm Description

Participants randomized to ampreloxetine will receive a single, oral, daily dose of active drug for 4 weeks.

Participants randomized to Placebo will receive a single, oral, daily dose of placebo for 4 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome.

Secondary Outcome Measures

Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score at Week 4
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome.
Change From Baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) Composite Score at Week 4
OHDAS is an assessment of how low blood pressure symptoms affect daily life. OHDAS is a 4 item assessment in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome.
Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4
PGI-C was assessed using a 5-point scale where participants were asked to compare their current condition to their condition at baseline from 1 to 5, with 1 indicating the condition is very much improved and 5 indicating the condition is very much worse. These scores were analyzed in 2 categories: better and no change/worse.
Number of Participants Who Experienced at Least One Fall

Full Information

First Posted
November 20, 2018
Last Updated
August 18, 2022
Sponsor
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT03750552
Brief Title
Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Acronym
SEQUOIA
Official Title
A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.
Detailed Description
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH. The study consists of 3 periods: (i) 4-week screening, (ii) 4-week randomized treatment, and (iii) 2-week follow up. The trial utilizes an operational design featuring the ability to conduct protocol required visits as either in clinic or remote visits (except Screening visit).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Neurogenic Orthostatic Hypotension
Keywords
Symptomatic Neurogenic Orthostatic Hypotension, symptomatic nOH, multiple system atrophy, MSA, Parkinson's disease, PD, pure autonomic failure, PAF, primary autonomic failure, SEQUOIA, ampreloxetine, low blood pressure, dizziness, fainting, blacking out, lightheadedness, norepinephrine, hypotension, Parkinsonism, TD-9855, Neurogenic Orthostatic Hypotension, nOH, 0145, 145, 169, 0169, TD9855

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ampreloxetine
Arm Type
Experimental
Arm Description
Participants randomized to ampreloxetine will receive a single, oral, daily dose of active drug for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to Placebo will receive a single, oral, daily dose of placebo for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
ampreloxetine
Other Intervention Name(s)
TD-9855
Intervention Description
Oral tablet, QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet, QD
Primary Outcome Measure Information:
Title
Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4
Description
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score at Week 4
Description
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome.
Time Frame
Baseline and Week 4
Title
Change From Baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) Composite Score at Week 4
Description
OHDAS is an assessment of how low blood pressure symptoms affect daily life. OHDAS is a 4 item assessment in which the composite score uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A mean negative change from baseline indicates a better outcome.
Time Frame
Baseline and Week 4
Title
Number of Participants Who Experienced an Improvement From Baseline in Patient Global Impression of Change (PGI-C) Score at Week 4
Description
PGI-C was assessed using a 5-point scale where participants were asked to compare their current condition to their condition at baseline from 1 to 5, with 1 indicating the condition is very much improved and 5 indicating the condition is very much worse. These scores were analyzed in 2 categories: better and no change/worse.
Time Frame
Baseline and Week 4
Title
Number of Participants Who Experienced at Least One Fall
Time Frame
Up to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is male or female and at least 30 years old. Subject must meet the diagnostic criteria of symptomatic nOH, as demonstrated by a sustained reduction in BP of ≥20 mm Hg (systolic) or ≥10 mm Hg (diastolic) within 3 minutes of being tilted-up to ≥60o from a supine position as determined by a tilt-table test. Subject must score at least a 4 on the Orthostatic Hypotension Symptom Assessment Question #1 at randomization visit. For subjects with PD only: Subject has a diagnosis of PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992). For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008). For subjects with PAF only: Subject has documented impaired autonomic reflexes, including the Valsalva maneuver performed within 24 months from the date of randomization. Subject has plasma NE levels >100 pg/mL after being in seated position for 30 minutes. Exclusion Criteria: Subject has a known systemic illness known to produce autonomic neuropathy, including but not limited to amyloidosis, and autoimmune neuropathies. Subject has a known intolerance to other NRIs or SNRIs. Subject currently uses concomitant antihypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction. Subject has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives, whichever is longer, prior to randomization or requires concomitant use until the follow-up visit. Subject has changed dose, frequency, or type of prescribed medication for orthostatic hypotension within 7 days prior to V1. Midodrine and droxidopa (if applicable) must be tapered off at least 7 days prior to V1. Subject has a known or suspected alcohol or substance abuse within the past 12 months (DSM-IV-TR® definition of alcohol or substance abuse). Subject has a clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months. Subject has used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to randomization. Subject has a history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the subject. Subject has any significant uncontrolled cardiac arrhythmia. Subject has a Montreal Cognitive Assessment (MoCA) ≤23. Subject had a myocardial infarction in the past 6 months or has current unstable angina. Subject has known congestive heart failure (New York Heart Association [NYHA] Class 3 or 4). Subject has a clinically significant abnormal laboratory findings (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3.0 x upper limit of normal [ULN]; blood bilirubin [total] >1.5 x ULN; estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or any abnormal laboratory value that could interfere with safety of the subject). Subject has demonstrated a history of lifetime suicidal ideation and/or suicidal behavior, as outlined by the C-SSRS (Columbia Suicide Severity Rating Scale) (Baseline/Screening Version) subject should be assessed by the rater for risk of suicide and the subject's appropriateness for inclusion in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Stanford Neuroscience Health Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Colorado Springs Neurological Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
University of Colorado Health
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Georgetown University Hospital, Dept. of Neurology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
SFM Clinical Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Fixel Institute for Neurological Diseases
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Neurostudies, Inc
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
NorthShore University Health System
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Georgetown University Hospital
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Facility Name
Inland Northwest Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Monash Health - Clinical Trials Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Perron Institute for Neurological and Translational Science, QEII Medical Centre
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Medizinische Universitat Innsbruck Abteilung Fur Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitätsklinikum Tulln
City
Tulln
ZIP/Postal Code
3430
Country
Austria
Facility Name
Wilhelminenspital Wien Abteilung fur Neurologie
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
UMHAT Sveti Georgi EAD Clinic of Neurological Diseases
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHATNP Sv.Naum, EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
UMHAT Alexandrovska EAD Clinic of Neurological Diseases
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
London Health Sciences Centre-CCIT
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University Health Network - Toronto Western Hospital Movement Disorders Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Bispebjerg og Frederiksberg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Astra Team Clinic
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Hopital Roger Salengro - CHU Lille
City
Lille Cedex
State/Province
Nord
Country
France
Facility Name
CHU Caremeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Hospital Pierre Paul Rquet, CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitaetsklinikum Freiburg - Klinik fur Neurologie und Neurophysiologie
City
Freiburg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. J. Springub/ W. Schwarz
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
Praxis Dr. Oehlwein
City
Gera
State/Province
Thueringen
ZIP/Postal Code
07551
Country
Germany
Facility Name
Charite Universitatsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12 203
Country
Germany
Facility Name
Alexianer St. Joseph-Krankenhaus Berlin-Weißensee, Klinik für Neurologie
City
Berlin
ZIP/Postal Code
13088
Country
Germany
Facility Name
Charite - Campus Virchow-Klinikum, Klinik fur Neurologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Charite - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Clinexpert Kft.
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem, Neurologiai Klinika
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Szent Borbala Korhaz
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
1311001
Country
Israel
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel HaShomer
ZIP/Postal Code
5262101
Country
Israel
Facility Name
Istituto Clinico Humanitas - IRCCS
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione Istituto G.Giglio di Cefalù
City
Cefalù
State/Province
Palermo
ZIP/Postal Code
90015
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Umberto I - G.M. Lancisi - G. Salesi, SOD Clinica di Neuroriabilitazione
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Policlinico Vittorio Emanuele. - P.O G. Rodolico, Clinica Neurologica
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Universita Gabriele D'Annunzio- Cesi-Met
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Raffaele I U.O. di Neurologia
City
Milano
ZIP/Postal Code
58-20132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Fondazione PTV - Policlinico Tor Vergata I U.O.C. Neurologia
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Ospedale San Giovanni Battista del Sovrano Militare Ordine di Malta
City
Roma
ZIP/Postal Code
00148
Country
Italy
Facility Name
Ospedale San Giovanni Battista
City
Roma
ZIP/Postal Code
00148
Country
Italy
Facility Name
Policlinico Umberto I - Universita degli Studi di Roma La Sapienza / Neurologia
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Sapienza University of Rome
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
AOU San Giovanni di Dio e Ruggi d'Aragona
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Facility Name
A.O. Santa Maria
City
Terni
ZIP/Postal Code
5100
Country
Italy
Facility Name
New Zealand Brain Research Institute
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
City
Katowice
ZIP/Postal Code
40-588
Country
Poland
Facility Name
PRATIA MCM Kraków
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Instytut Zdrowia dr Boczarska-Jedynak
City
Oświęcim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
NEURO-CARE Sp. z o.o. Sp. Komandytowa
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
ETG Warszawa
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Specjalistyczne Gabinety sp. z o.o.
City
Warszawa
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Hospital Senhora da Oliveira - Guimaraes, EPE
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar e Universitario Lisboa Norte - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Campus Neurologico Senior
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal
Facility Name
State Autonomous Institution of Healthcare Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Additional Professional Education Russian Medical Academy of Continuous Postgraduate Education of the Ministry of Healthcare of the Russian Federation
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
NHI Central Clinical Hospital #2 of JSC Russian Railways N.A. Semashko
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
City Neurological Center Sibneiromed
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
SBEIHPE Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Federal State Budgetary Institution National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the Ministry of Healthcare of the Russian Federation
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Human Brain Institute RAMS
City
Saint Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Institution of Healthcare City Hospital # 40 of Kurortnyi Region
City
Saint Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Regional State Budgetary Institution of Healthcare Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Hospital Universitario Donostia
City
San Sebastián
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Navarrabiomed Fundacion Miguel Servet
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Mutua de Terrasa
City
Barcelona
ZIP/Postal Code
08222
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Communal Institution Dnipropetrovsk I.I.Mechnikov RCH
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61172
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Dept of Neurology
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Communal Institution City Clinical Hospital #6
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Re:Cognition Health
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
Facility Name
Barts Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
The National Hospital for Neurology & Neurosurgery
City
London
State/Province
Greater London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
Manchester
ZIP/Postal Code
SES 9PJ
Country
United Kingdom
Facility Name
Re:Cognition Health Ltd
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B16 8LT
Country
United Kingdom
Facility Name
Re:Cognition Health
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Salford Royal
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

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