Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

PHASE3TerminatedINTERVENTIONAL
Enrollment

203

Participants

Timeline

Start Date

February 22, 2019

Primary Completion Date

November 10, 2021

Study Completion Date

November 10, 2021

Conditions
Symptomatic Neurogenic Orthostatic HypotensionMSAParkinson's Disease (PD)Pure Autonomic Failure (PAF)
Interventions
DRUG

ampreloxetine

Oral tablet, QD (Daily)

DRUG

Placebo

Oral tablet, QD

Trial Locations (82)

1083

Semmelweis Egyetem, Neurologiai Klinika, Budapest

1113

MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders, Sofia

2400

Bispebjerg Hospital, Copenhagen

3050

The Royal Melbourne Hospital Neurology Department, Parkville

3168

Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre, Clayton

3430

Universitatsklinikum Tulln Abteilung fur Neurologie, Tulln

5000

Odense Universitetshospital, Odense

6009

Perron Institute for Neurological and Translational Science, Nedlands

6020

Medizinische Universitat Innsbruck, Abteilung fur Neurologie, Innsbruck

7551

Praxis Dr. med. Christian Oehlwein, Gera

8011

New Zealand Brain Research Institute, Christchurch

10016

New York University Langone Health, New York

10138

East Tallinn Central Hospital, Tallinn

11315

Astra Team Clinic, Tallinn

12203

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin

13353

Charite - Campus Virchow-Klinikum, Klinik fur Neurologie, Berlin

20122

Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico, Milan

21005

Communal Institution Acad. O.I. Yuschenko VRPsH Vinnytsia M.I. Pyrogov NMU Ch of ND with the Course of Neurosurgery, Vinnytsia

22101

Georgetown University Hospital, McLean

27157

Wake Forest University Baptist Health Sciences, Winston-Salem

28006

Hospital Universitario de La Princesa, Madrid

30029

CHU de Nîmes - Hôpital Caremeau, Nîmes

31008

Complejo Hospitalario de Navarra, Pamplona

33486

Parkinson's Disease and Movement Disorders Center, Boca Raton

33487

SFM Clinical Research, LLC, Boca Raton

33952

Neurostudies, Inc, Port Charlotte

37232

Vanderbilt University Medical Center, Nashville

40139

Universita di Bologna-Clinica Neurologica - Dipt di Scienze Neurologiche Ospedale Bellaria, Bologna

43210

Ohio State University - Wexner Medical Center, Columbus

45219

University of Cincinnati Medical Center (UCGNI), Cincinnati

48903

Hospital de Cruces, Bilbao

50406

Tartu University Hospital, Tartu

55905

Mayo Clinic, Rochester

56126

Azienda Ospedaliero-Universitaria Pisana- Ospedale S. Chiara, U.O. di Neurologia - Neurofisiopatologia, Pisa

60026

NorthShore University Health System, Glenview

60612

Rush University Medical Center, Chicago

61172

Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council, Kharkiv

66100

Universita degli studi Gabriele D' Annunzio Chieti, Chieti

66160

University of Kansas Medical Center Research Institute, Inc., Kansas City

75390

University of Texas Southwestern Medical Center, Dallas

76100

Kaplan Medical Center, Rehovot

79010

Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Lviv

80907

Colorado Springs Neurological Associates, PC, Colorado Springs

84131

AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno

85351

Banner Sun Health Research Institute, Sun City

92307

UC San Diego Movement Disorder Center, La Jolla

94304

Stanford Neuroscience Health Center, Palo Alto

95125

Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico), Catania

97239

Oregon Health & Science University, Portland

99202

Inland Northwest Research, Spokane

192019

FSBI National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the MOH of the Russian Federation, Saint Petersburg

197376

FSBI of Science Institute of Human Brain named after N .P. Bekhtereva of Russian Academy of Sciences, Saint Petersburg

197706

Saint Petersburg State Budgetary Institution of Healthcare City Hospital #40 of Kurortnyi Region, Saint Petersburg

630054

State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital #34, Novosibirsk

630091

City Neurological Center Sibneiromed, LLC, Novosibirsk

660037

FSBI Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency, Krasnoyarsk

4941492

Rabin Medical Center, Beilinson Campus, Petah Tikva

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

02139

Concord Hospital, Neurosciences Department, Concord

T2N 4Z6

University of Calgary Teaching Research and Wellness Building, Calgary

M5T 2S8

Toronto Western Hospital, Toronto

H3A 2B4

Montreal Neurological Institute & Hospital, Montreal

00133

Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia, Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento, Roma

05100

A.O. Santa Maria, Terni

40-588

Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala, Katowice

31-505

Krakowska Akademia Neurologii Sp. Zo.o. Centrum Neurologii Klinicznej, Krakow

32-600

Instytut Zdrowia dr Boczarska-Jedynak, Oświęcim

41-100

NEURO-CARE Sp. z o.o. Sp. Komandytowa, Siemianowice Śląskie

02-777

ETG Warszawa, Warsaw

30-539

Specjalistyczne Gabinety sp. z o.o., Warsaw

4835-044

Hospital da Senhora da Oliveira Guimarães, Guimarães

2560-280

CNS-Campus Neurologico Senior, Torres Vedras

08221

Hospital Universitario Mutua de Terrasa, Terrassa

08003

Hospital del Mar, Barcelona

EX2 5DW

Royal Devon and Exeter Hospital NHS Trust, Exeter

PL6 8BT

Cognition Health Unit 2, Plymouth

M6 8HD

Salford Royal NHS Foundation Trust, Salford

EC1M 6BQ

Clinical Research Centre, William Harvey Heart Centre, London

SE5 9RS

King's College Hospital, London

W1G 9JF

Re:Cognition Health Ltd, London

WC1N 3BG

The National Hospital for Neurology & Neurosurgery, London

Sponsors
All Listed Sponsors
lead

Theravance Biopharma

INDUSTRY

NCT03829657 - Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure | Biotech Hunter | Biotech Hunter