Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
NCT ID: NCT04095793
Last Updated: 2022-11-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
110 participants
INTERVENTIONAL
2019-09-19
2021-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ampreloxetine
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
ampreloxetine
Oral tablet, QD
Interventions
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ampreloxetine
Oral tablet, QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
30 Years
ALL
No
Sponsors
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Theravance Biopharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Theravance Biopharma
Locations
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Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Neurostudies, Inc.
Port Charlotte, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
NorthShore University HealthSystem
Glenview, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
New York University School of Medicine
New York, New York, United States
University of Cincinnati Medical Center (UCGNI)
Cincinnati, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Inland Northwest Research
Spokane, Washington, United States
Concord Hospital, Neurosciences Department
Concord, New South Wales, Australia
Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre
Clayton, Victoria, Australia
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, Australia
Universitätsklinikum Tulln Abteilung fur Neurologie
Tulln, , Austria
MHATNP -Sv. Naum- EAD
Sofia, , Bulgaria
MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders
Sofia, , Bulgaria
Montreal Neurological Institute & Hospital
Montreal, Quebec, Canada
Bispebjerg Hospital
Copenhagen, , Denmark
Tartu University Hospital
Tartu, , Estonia
CHU de Nîmes - Hôpital Caremeau
Nîmes, Gard, France
Praxis Dr. med. Christian Oehlwein
Gera, Thuringia, Germany
Charite - Campus Virchow- Klinikum, Klinik fur Neurologie
Berlin, , Germany
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Ospedaliera Santa Maria Terni
Terni, Umbria, Italy
Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
Bologna, , Italy
UO Farmacia Centralizzata OM (SC) Ospedale Maggiore
Bologna, , Italy
Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia
Milan, , Italy
Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
Roma, , Italy
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno, , Italy
New Zealand Brain Research Institute
Christchurch, , New Zealand
Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
Katowice, , Poland
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
Krakow, , Poland
Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.
Oświęcim, , Poland
Neuro-Care Sp. z o.o. sp. Komandytowa
Siemianowice Śląskie, , Poland
ETG Warszawa
Warsaw, , Poland
Specjalistyczn.e Gabinety Sp. Z o.o.
Warsaw, , Poland
Campus Neurologico Senior
Torres Vedras, , Portugal
Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
Krasnoyarsk, , Russia
Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
Krasnoyarsk, , Russia
SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF
Moscow, , Russia
Limited Liability Company City Neurological Center Sibneiromed
Novosibirsk, , Russia
State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34
Novosibirsk, , Russia
FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation
Saint Petersburg, , Russia
Hospital del Mar
Barcelona, , Spain
Hospital de Cruces
Bilbao, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine
Kharkiv, , Ukraine
Lviv Regional Clinical Hospital
Lviv, , Ukraine
CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
Vinnytsia, , Ukraine
The National Hospital for Neurology & Neurosurgery
London, Greater London, United Kingdom
Re:Cognition Health Ltd
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-002425-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0171
Identifier Type: -
Identifier Source: org_study_id
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