Clinical trial NCT04095793: Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Official title: A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Symptomatic Neurogenic Orthostatic Hypotension
Keywords: Symptomatic Neurogenic Orthostatic Hypotension
sympomatic nOH
multiple symptom atrophy
MSA
Parkinson's disease
PD
pure autonomic failure
PAF
orthostatic hypotension
OH
ampreloxetine
171
low blood pressure
dizziness
fainting
blacking out
lightheadedness
norepinephrine
hypotension
OAK
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to a maximum of 749 days
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies, Inc.
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center (UCGNI)
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Spokane
country: United States
facility: Inland Northwest Research
state: Washington
city: Concord
country: Australia
facility: Concord Hospital, Neurosciences Department
state: New South Wales
city: Clayton
country: Australia
facility: Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre
state: Victoria
city: Nedlands
country: Australia
facility: Perron Institute for Neurological and Translational Science
state: Western Australia
city: Tulln
country: Austria
facility: Universitätsklinikum Tulln Abteilung fur Neurologie
city: Sofia
country: Bulgaria
facility: MHATNP -Sv. Naum- EAD
city: Sofia
country: Bulgaria
facility: MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders
city: Montréal
country: Canada
facility: Montreal Neurological Institute & Hospital
state: Quebec
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Caremeau
state: Gard
city: Gera
country: Germany
facility: Praxis Dr. med. Christian Oehlwein
state: Thueringen
city: Berlin
country: Germany
facility: Charite - Campus Virchow- Klinikum, Klinik fur Neurologie
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Terni
country: Italy
facility: Ospedaliera Santa Maria Terni
state: Umbria
city: Bologna
country: Italy
facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
city: Bologna
country: Italy
facility: UO Farmacia Centralizzata OM (SC) Ospedale Maggiore
city: Milano
country: Italy
facility: Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia
city: Roma
country: Italy
facility: Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
city: Salerno
country: Italy
facility: AOU San Giovanni di Dio e Ruggi d'Aragona
city: Christchurch
country: New Zealand
facility: New Zealand Brain Research Institute
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
city: Kraków
country: Poland
facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
city: Oswiecim
country: Poland
facility: Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.
city: Siemianowice Śląskie
country: Poland
facility: Neuro-Care Sp. z o.o. sp. Komandytowa
city: Warszawa
country: Poland
facility: ETG Warszawa
city: Warszawa
country: Poland
facility: Specjalistyczn.e Gabinety Sp. Z o.o.
city: Torres Vedras
country: Portugal
facility: Campus Neurologico Senior
city: Krasnoyarsk
country: Russian Federation
facility: Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
city: Krasnoyarsk
country: Russian Federation
facility: Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
city: Moscow
country: Russian Federation
facility: SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company City Neurological Center Sibneiromed
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34
city: Saint Petersburg
country: Russian Federation
facility: FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Kharkiv
country: Ukraine
facility: Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
city: London
country: United Kingdom
facility: The National Hospital for Neurology & Neurosurgery
state: Greater London
city: London
country: United Kingdom
facility: Re:Cognition Health Ltd
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: