Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension
- Interventions
- Registration Number
- NCT04095793
- Lead Sponsor
- Theravance Biopharma
- Brief Summary
A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.
- Detailed Description
This is a Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 110
- Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with ampreloxetine.
- The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
- The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of >4 in OHSA#1.
- Subjects may not be enrolled in another clinical trial.
- Psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
- Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
- Hypersensitivity to ampreloxetine or the formulation excipients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ampreloxetine ampreloxetine Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) Day 1 up to a maximum of 749 days An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period.
Clinically significant abnormalities in physical and neurological examinations, vital signs, resting 12-lead electrocardiograms, and clinical laboratory evaluations, in addition to incidence of fall, suicidal ideation, and suicidal behavior, were reported as AEs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (55)
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
NorthShore University HealthSystem
๐บ๐ธGlenview, Illinois, United States
University of Texas Southwestern Medical Center
๐บ๐ธDallas, Texas, United States
MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders
๐ง๐ฌSofia, Bulgaria
Tel Aviv Sourasky Medical Center
๐ฎ๐ฑTel Aviv, Israel
Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
๐ท๐บKrasnoyarsk, Russian Federation
Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
๐ท๐บKrasnoyarsk, Russian Federation
FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation
๐ท๐บSaint Petersburg, Russian Federation
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
๐ต๐ฑKrakรณw, Poland
New Zealand Brain Research Institute
๐ณ๐ฟChristchurch, New Zealand
Perron Institute for Neurological and Translational Science
๐ฆ๐บNedlands, Western Australia, Australia
Ospedaliera Santa Maria Terni
๐ฎ๐นTerni, Umbria, Italy
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
Bispebjerg Hospital
๐ฉ๐ฐCopenhagen, Denmark
UO Farmacia Centralizzata OM (SC) Ospedale Maggiore
๐ฎ๐นBologna, Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia
๐ฎ๐นMilano, Italy
Neurostudies, Inc.
๐บ๐ธPort Charlotte, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
๐บ๐ธBoca Raton, Florida, United States
Mayo Clinic - Rochester
๐บ๐ธRochester, Minnesota, United States
New York University School of Medicine
๐บ๐ธNew York, New York, United States
University of Cincinnati Medical Center (UCGNI)
๐บ๐ธCincinnati, Ohio, United States
Oregon Health & Science University (OHSU)
๐บ๐ธPortland, Oregon, United States
Inland Northwest Research
๐บ๐ธSpokane, Washington, United States
Concord Hospital, Neurosciences Department
๐ฆ๐บConcord, New South Wales, Australia
Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre
๐ฆ๐บClayton, Victoria, Australia
MHATNP -Sv. Naum- EAD
๐ง๐ฌSofia, Bulgaria
Universitรคtsklinikum Tulln Abteilung fur Neurologie
๐ฆ๐นTulln, Austria
Montreal Neurological Institute & Hospital
๐จ๐ฆMontrรฉal, Quebec, Canada
Praxis Dr. med. Christian Oehlwein
๐ฉ๐ชGera, Thueringen, Germany
Tartu University Hospital
๐ช๐ชTartu, Estonia
CHU de Nรฎmes - Hรดpital Caremeau
๐ซ๐ทNรฎmes, Gard, France
Charite - Campus Virchow- Klinikum, Klinik fur Neurologie
๐ฉ๐ชBerlin, Germany
Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
๐ฎ๐นBologna, Italy
Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia
๐ฎ๐นRoma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
๐ฎ๐นRoma, Italy
Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
๐ต๐ฑKatowice, Poland
AOU San Giovanni di Dio e Ruggi d'Aragona
๐ฎ๐นSalerno, Italy
Specjalistyczn.e Gabinety Sp. Z o.o.
๐ต๐ฑWarszawa, Poland
Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.
๐ต๐ฑOswiecim, Poland
Neuro-Care Sp. z o.o. sp. Komandytowa
๐ต๐ฑSiemianowice ลlฤ skie, Poland
ETG Warszawa
๐ต๐ฑWarszawa, Poland
Campus Neurologico Senior
๐ต๐นTorres Vedras, Portugal
SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF
๐ท๐บMoscow, Russian Federation
State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34
๐ท๐บNovosibirsk, Russian Federation
Limited Liability Company City Neurological Center Sibneiromed
๐ท๐บNovosibirsk, Russian Federation
Hospital de Cruces
๐ช๐ธBilbao, Spain
Hospital del Mar
๐ช๐ธBarcelona, Spain
Hospital Universitario de La Princesa
๐ช๐ธMadrid, Spain
Lviv Regional Clinical Hospital
๐บ๐ฆLviv, Ukraine
Re:Cognition Health Ltd
๐ฌ๐งLondon, United Kingdom
Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine
๐บ๐ฆKharkiv, Ukraine
CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
๐บ๐ฆVinnytsia, Ukraine
The National Hospital for Neurology & Neurosurgery
๐ฌ๐งLondon, Greater London, United Kingdom
Colorado Springs Neurological Associates
๐บ๐ธColorado Springs, Colorado, United States
University of Kansas Medical Center
๐บ๐ธKansas City, Kansas, United States