A Phase 3, Multi-center, Randomized Withdrawal and Long Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants With Multiple System Atrophy

Status: Active_not_recruiting
Location: See all (79) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:

• Participant is male or female and at least 30 years old.

• Participant 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).

• Participant has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) confirmed by the Enrollment Steering Committee (ESC).

• Participant must meet the diagnostic criteria of nOH, as demonstrated by a sustained reduction in BP of ≥20 mmHg (systolic) or ≥10 mmHg (diastolic) within 3 min of standing as part of orthostatic standing test or being tilted up ≥60o from a supine position as determined by a tilt-table test.

• Participant must score ≤4 on UMSARS Part IV at Visit 1 (Screening).

• Participant must score at least a 4 on the OHSA item 1 at Visit 2 (Day 1).

• Participant must be willing to not take any prohibited medications during the study.

• If participant is female, the participant must not be pregnant, breastfeeding, or planning a pregnancy during the course of the study. A woman of childbearing potential must have a documented negative pregnancy test at screening.

• During the study and for 30 days after receiving the last dose of the study drug, females of childbearing potential or males capable of fathering children must agree to use highly effective birth control measures (failure rate \<1% when used consistently and correctly) or agree to abstain from sexual intercourse.

• Participant is willing and able to provide signed and dated written informed consent to -participate prior to initiation of any study related procedures.

⁃ Participant is able to communicate well with the Investigator and clinic staff, understands the expectations of the study and is able to comply with the study procedures, requirements, and restrictions.

Locations
United States
Arizona
Movement Disorders Center of Arizona
Scottsdale
California
The Parkinson's and Movement Disorder Institute
Fountain Valley
UC San Diego Movement Disorder Center
La Jolla
David Geffen School of Medicine at UCLA
Los Angeles
Stanford Neuroscience Health Center
Palo Alto
Washington, D.c.
Medstar Georgetown University Hospital
Washington D.c.
Florida
Parkinson's Disease And Movement Disorders Center of Boca Raton
Boca Raton
SFM Clinical Research, LLC
Boca Raton
Aqualane Clinical Research
Naples
Neurostudies, Inc
Port Charlotte
University of South Florida Ataxia Research Center
Tampa
Georgia
Emory University
Atlanta
Hawaii
Hawaii Pacific Neuroscience
Honolulu
Illinois
Rush University Medical Center
Chicago
Northshore University Health System
Glenview
Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City
Massachusetts
Brigham and Women's Hospital (Neuromuscular Division)
Boston
Massachusetts Chan Medical School
Worcester
Michigan
Quest Research Institute
Farmington Hills
New York
NYU Langone Health NYU Dysautonomia Center
New York
The Neurological Institute at Columbia University Medical Center
New York
Ohio
University of Cincinnati Medical Center
Cincinnati
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
University of Texas Southwestern Medical Center
Dallas
Baylor College of Medicine
Houston
Utah
Movement Disorders and Autonomic Disorders Clinic; University of Utah
Salt Lake City
Other Locations
Argentina
Hospital Británico de Buenos Aires
Caba
Hospital General de Agudos Jose Maria Ramos Mejía
Caba
INEBA Instituto Neurociencias Buenos Aires
Caba
Instituto Fleni
Caba
Médico/Hospital de la Policía Federal Churruca Visca
Caba
Fundación Scherbovsky
Mendoza
Australia
Monash Health
Clayton
The Alfred Hospital
Melbourne
Theravance Biopharma Investigative Site
Parkville
Austria
Medical University of Innsbruck
Innsbruck
Universitatsklinikum Tulln
Tulln
Brazil
Hospital de Clínicas - Universidade Federal de Minas Gerais (HC - UFMG)
Belo Horizonte
Instituto de Neurologia de Curitiba S\C LTDA
Curitiba
Centro de Pesquisa Clínica (CPC) do Hospital das Clínicas de Porto Alegre (HCPA)
Porto Alegre
Hospital São Lucas - PUCRS
Porto Alegre
Canada
University of Calgary - Health Sciences Centre
Calgary
Denmark
Bispebjerg Hospital
Copenhagen
Estonia
Astra Clinic (Clinic4U)
Tallinn
Tartu University Hospital
Tartu
France
Centre Hospitalier Universitaire de Bordeaux Health
Bordeaux
Hopital Caremeau
Nîmes
Centre d'Investigation Clinique Hôpital Pierre Paul Rique
Toulouse
Germany
Charité - Universitätsmedizin Berlin- Campus Mitte
Berlin
Charite Universitaetsmedizin Berlin
Berlin
Praxis Dr. Oehlwein, Outpatient Clinic
Gera
Hungary
Semmelweis Egyetem
Budapest
Israel
Theravance Biopharma Investigative Site
Tel Aviv
Italy
IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)
Bologna
Parkinson's Centre of Ospedale CTO
Milan
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno
Salerno
Azienda Ospedaliera Santa Maria di Terni
Terni
Santa Chiara Hospital
Trento
Pia Fond. Cardinale Giovanni Panico Azienda Ospedaliera
Tricase
New Zealand
Theravance Biopharma Investigative Site
Christchurch
Auckland City Hospital
Grafton
Poland
Neurocentrum-Miwomed
Gdansk
Neuro-Care Sp. z o.o. Sp. Komandytowa
Katowice
Krakowska Akademia Neurologii Sp.zo.o.
Krakow
Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o., Sp.k.
Oświęcim
Portugal
CNS-Campus Neurologico Senior
Torres Vedras
Serbia
University of Belgrade Neurology Clinic
Belgrade
Spain
Hospital Germans Trias i Pujol, Department of Neurology
Barakaldo
Instituto Investigación Sanitaria Biocruces
Barakaldo
Hospital Universitario de La Princesa
Madrid
Hospital Universitario Infante Sofia Paseo Europa
Madrid
Fundació Assistencial Mutua de Terrassa
Terrassa
Taiwan
National Taiwan University Cancer Center
Taipei
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Autonomic Unit, National Hospital for Neurology & Neurosurgery
London
Barts Health
London
Salford Royal Hospital
Salford
Time Frame
Start Date: 2023-06-27
Completion Date: 2028-01
Participants
Target number of participants: 102
Treatments
Active_comparator: Ampreloxetine (Open Label)
Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 12 weeks.
Placebo_comparator: Ampreloxetine (Randomized Withdrawal)
After completing the open label, participants are randomized to either ampreloxetine or placebo receiving a single, oral, daily dose of active drug or placebo for a further 8 weeks.
Active_comparator: Long-Term Extension Period
Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 104 weeks.
Sponsors
Leads: Theravance Biopharma

This content was sourced from clinicaltrials.gov