Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
- Conditions
- Symptomatic Neurogenic Orthostatic HypotensionMSAParkinson's Disease (PD)Pure Autonomic Failure (PAF)
- Interventions
- Drug: Placebo
- Registration Number
- NCT03829657
- Lead Sponsor
- Theravance Biopharma
- Brief Summary
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
- Detailed Description
Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in efficacy and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH. The study consists of 3 periods: (i) 16-week open-label (OL) treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled treatment, and (iii) 2-week follow-up (only for patients who do not enroll in Study 0171 (long-term extension safety study)).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 203
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ampreloxetine ampreloxetine After completing the OL, participants randomized to ampreloxetine will receive single, oral, daily dose of active drug for a further 6 weeks. ampreloxetine (Open Label (OL)) ampreloxetine Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 16 weeks. Placebo Placebo After completing the OL, participants randomized to Placebo will receive single, oral, daily dose of placebo for 6 weeks.
- Primary Outcome Measures
Name Time Method Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period 6-week randomized withdrawal period (Week 16 to Week 22) Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity.
Least squares mean here is the model-based proportion of participants with treatment failure using logistic regression.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (82)
Parkinson's Disease and Movement Disorders Center
🇺🇸Boca Raton, Florida, United States
SFM Clinical Research, LLC
🇺🇸Boca Raton, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
NorthShore University Health System
🇺🇸Glenview, Illinois, United States
Krakowska Akademia Neurologii Sp. Zo.o. Centrum Neurologii Klinicznej
🇵🇱Kraków, Poland
Hospital da Senhora da Oliveira Guimarães
🇵🇹Guimarães, Portugal
Universitatsklinikum Tulln Abteilung fur Neurologie
🇦🇹Tulln, Austria
Tartu University Hospital
🇪🇪Tartu, Estonia
NEURO-CARE Sp. z o.o. Sp. Komandytowa
🇵🇱Siemianowice Śląskie, Poland
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Wake Forest University Baptist Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Stanford Neuroscience Health Center
🇺🇸Palo Alto, California, United States
Colorado Springs Neurological Associates, PC
🇺🇸Colorado Springs, Colorado, United States
UC San Diego Movement Disorder Center
🇺🇸La Jolla, California, United States
University of Cincinnati Medical Center (UCGNI)
🇺🇸Cincinnati, Ohio, United States
Ohio State University - Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Praxis Dr. med. Christian Oehlwein
🇩🇪Gera, Germany
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital de Cruces
🇪🇸Bilbao, Vizcaya, Spain
Concord Hospital, Neurosciences Department
🇦🇺Concord, New South Wales, Australia
East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Odense Universitetshospital
🇩🇰Odense, Denmark
Rabin Medical Center, Beilinson Campus
🇮🇱Petah Tikva, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)
🇮🇹Catania, Italy
AOU San Giovanni di Dio e Ruggi d'Aragona
🇮🇹Salerno, Italy
Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala
🇵🇱Katowice, Poland
CNS-Campus Neurologico Senior
🇵🇹Torres Vedras, Portugal
FSBI of Science Institute of Human Brain named after N .P. Bekhtereva of Russian Academy of Sciences
🇷🇺Saint Petersburg, Russian Federation
City Neurological Center Sibneiromed, LLC
🇷🇺Novosibirsk, Russian Federation
Royal Devon and Exeter Hospital NHS Trust
🇬🇧Exeter, Devon, United Kingdom
The National Hospital for Neurology & Neurosurgery
🇬🇧London, United Kingdom
Saint Petersburg State Budgetary Institution of Healthcare City Hospital #40 of Kurortnyi Region
🇷🇺Saint Petersburg, Sestroretsk, Russian Federation
FSBI National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the MOH of the Russian Federation
🇷🇺Saint Petersburg, Russian Federation
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Neurostudies, Inc
🇺🇸Port Charlotte, Florida, United States
New York University Langone Health
🇺🇸New York, New York, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Georgetown University Hospital
🇺🇸McLean, Virginia, United States
Inland Northwest Research
🇺🇸Spokane, Washington, United States
The Royal Melbourne Hospital Neurology Department
🇦🇺Parkville, Victoria, Australia
MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders
🇧🇬Sofia, Bulgaria
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
University of Calgary Teaching Research and Wellness Building
🇨🇦Calgary, Alberta, Canada
Montreal Neurological Institute & Hospital
🇨🇦Montreal, Quebec, Canada
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
CHU de Nîmes - Hôpital Caremeau
🇫🇷Nîmes, France
Charite - Campus Virchow-Klinikum, Klinik fur Neurologie
🇩🇪Berlin, Germany
Semmelweis Egyetem, Neurologiai Klinika
🇭🇺Budapest, Hungary
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Universita di Bologna-Clinica Neurologica - Dipt di Scienze Neurologiche Ospedale Bellaria
🇮🇹Bologna, Italy
Universita degli studi Gabriele D' Annunzio Chieti
🇮🇹Chieti, Italy
Azienda Ospedaliero-Universitaria Pisana- Ospedale S. Chiara, U.O. di Neurologia - Neurofisiopatologia
🇮🇹Pisa, Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
A.O. Santa Maria
🇮🇹Terni, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
🇮🇹Roma, Italy
Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia
🇮🇹Roma, Italy
New Zealand Brain Research Institute
🇳🇿Christchurch, New Zealand
FSBI Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
🇷🇺Krasnoyarsk, Russian Federation
State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital #34
🇷🇺Novosibirsk, Russian Federation
Hospital Universitario Mutua de Terrasa
🇪🇸Terrassa, Barcelona, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council
🇺🇦Kharkiv, Ukraine
Cognition Health Unit 2
🇬🇧Plymouth, Devon, United Kingdom
Salford Royal NHS Foundation Trust
🇬🇧Salford, Greater Manchester, United Kingdom
Clinical Research Centre, William Harvey Heart Centre
🇬🇧London, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Perron Institute for Neurological and Translational Science
🇦🇺Nedlands, Western Australia, Australia
Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Re:Cognition Health Ltd
🇬🇧London, United Kingdom
University of Kansas Medical Center Research Institute, Inc.
🇺🇸Kansas City, Kansas, United States
Astra Team Clinic
🇪🇪Tallinn, Estonia
Medizinische Universitat Innsbruck, Abteilung fur Neurologie
🇦🇹Innsbruck, Austria
Instytut Zdrowia dr Boczarska-Jedynak
🇵🇱Oswiecim, Poland
ETG Warszawa
🇵🇱Warszawa, Poland
Specjalistyczne Gabinety sp. z o.o.
🇵🇱Warszawa, Poland
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
🇺🇦Lviv, Ukraine
Communal Institution Acad. O.I. Yuschenko VRPsH Vinnytsia M.I. Pyrogov NMU Ch of ND with the Course of Neurosurgery
🇺🇦Vinnytsia, Ukraine