Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

June 27, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2028

Conditions
Symptomatic Neurogenic Orthostatic HypotensionMSA - Multiple System Atrophy
Interventions
DRUG

Ampreloxetine

Oral tablet, QD

DRUG

Placebo

Oral tablet, QD

Trial Locations (79)

106

National Taiwan University Cancer Center, Taipei

1023

Auckland City Hospital, Grafton

1085

Semmelweis Egyetem, Budapest

3050

Theravance Biopharma Investigative Site, Parkville

3168

Monash Health, Clayton

The Alfred Hospital, Melbourne

8011

Theravance Biopharma Investigative Site, Christchurch

10016

NYU Langone Health NYU Dysautonomia Center, New York

10032

The Neurological Institute at Columbia University Medical Center, New York

10117

Charité - Universitätsmedizin Berlin- Campus Mitte, Berlin

11000

University of Belgrade Neurology Clinic, Belgrade

11315

Astra Clinic (Clinic4U), Tallinn

12203

Charite Universitaetsmedizin Berlin, Berlin

20007

Medstar Georgetown University Hospital, Washington D.C.

20126

Parkinson's Centre of Ospedale CTO, Milan

28006

Hospital Universitario de La Princesa, Madrid

28702

Hospital Universitario Infante Sofia Paseo Europa, Madrid

30029

Tartu University Hospital, Tartu

30329

Emory University, Atlanta

33076

Centre Hospitalier Universitaire de Bordeaux Health, Bordeaux

33486

Parkinson's Disease And Movement Disorders Center of Boca Raton, Boca Raton

33487

SFM Clinical Research, LLC, Boca Raton

33612

University of South Florida Ataxia Research Center, Tampa

33952

Neurostudies, Inc, Port Charlotte

34105

Aqualane Clinical Research, Naples

37232

Vanderbilt University Medical Center, Nashville

38122

Santa Chiara Hospital, Trento

40139

IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB), Bologna

45219

University of Cincinnati Medical Center, Cincinnati

48334

Quest Research Institute, Farmington Hills

48903

Hospital Germans Trias i Pujol, Department of Neurology, Barakaldo

Instituto Investigación Sanitaria Biocruces, Barakaldo

60612

Rush University Medical Center, Chicago

64239

Theravance Biopharma Investigative Site, Tel Aviv

66160

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

73039

Pia Fond. Cardinale Giovanni Panico Azienda Ospedaliera, Tricase

75390

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

84108

Movement Disorders and Autonomic Disorders Clinic; University of Utah, Salt Lake City

84131

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

85258

Movement Disorders Center of Arizona, Scottsdale

90095

David Geffen School of Medicine at UCLA, Los Angeles

92037

UC San Diego Movement Disorder Center, La Jolla

92708

The Parkinson's and Movement Disorder Institute, Fountain Valley

94304

Stanford Neuroscience Health Center, Palo Alto

96817

Hawaii Pacific Neuroscience, Honolulu

60026-1339

Northshore University Health System, Glenview

02115

Brigham and Women's Hospital (Neuromuscular Division), Boston

01655

Massachusetts Chan Medical School, Worcester

C1192AAW

INEBA Instituto Neurociencias Buenos Aires, CABA

C1428AQK

Instituto Fleni, CABA

C1437JCP

Médico/Hospital de la Policía Federal Churruca Visca, CABA

C1221ADC

Hospital General de Agudos Jose Maria Ramos Mejía, CABA

C1280AEB

Hospital Británico de Buenos Aires, CABA

M5500

Fundación Scherbovsky, Mendoza

A-6020

Medical University of Innsbruck, Innsbruck

Unknown

Universitatsklinikum Tulln, Tulln

81210-310

Instituto de Neurologia de Curitiba S\C LTDA, Curitiba

30130-100

Hospital de Clínicas - Universidade Federal de Minas Gerais (HC - UFMG), Belo Horizonte

90035-903

Centro de Pesquisa Clínica (CPC) do Hospital das Clínicas de Porto Alegre (HCPA), Porto Alegre

90610-000

Hospital São Lucas - PUCRS, Porto Alegre

T2N 4Z6

University of Calgary - Health Sciences Centre, Calgary

2400-NV

Bispebjerg Hospital, Copenhagen

Cedex 9

Hopital Caremeau, Nîmes

31059 Cedex

Centre d'Investigation Clinique Hôpital Pierre Paul Rique, Toulouse

07551

Praxis Dr. Oehlwein, Outpatient Clinic, Gera

00133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

I-05100

Azienda Ospedaliera Santa Maria di Terni, Terni

80-207

Neurocentrum-Miwomed, Gdansk

40-749

Neuro-Care Sp. z o.o. Sp. Komandytowa, Katowice

31-505

Krakowska Akademia Neurologii Sp.zo.o., Krakow

32-600

Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o., Sp.k., Oświęcim

2560-280

CNS-Campus Neurologico Senior, Torres Vedras

08222

Fundació Assistencial Mutua de Terrassa, Terrassa

B15 2GW

University Hospitals Birmingham NHS Foundation Trust, Birmingham

EC1M 6BQ

Barts Health, London

WC1N 3BG

Autonomic Unit, National Hospital for Neurology & Neurosurgery, London

M6 8HD

Salford Royal Hospital, Salford

Sponsors
All Listed Sponsors
lead

Theravance Biopharma

INDUSTRY

NCT05696717 - Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy | Biotech Hunter | Biotech Hunter