Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (OAK)
Primary Purpose
Symptomatic Neurogenic Orthostatic Hypotension
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ampreloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Neurogenic Orthostatic Hypotension focused on measuring 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
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.
Sites / Locations
- Colorado Springs Neurological Associates
- Parkinson's Disease and Movement Disorders Center of Boca Raton
- Neurostudies, Inc.
- Rush University Medical Center
- NorthShore University HealthSystem
- University of Kansas Medical Center
- Mayo Clinic - Rochester
- New York University School of Medicine
- University of Cincinnati Medical Center (UCGNI)
- Oregon Health & Science University (OHSU)
- Vanderbilt University Medical Center
- University of Texas Southwestern Medical Center
- Inland Northwest Research
- Concord Hospital, Neurosciences Department
- Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre
- Perron Institute for Neurological and Translational Science
- Universitätsklinikum Tulln Abteilung fur Neurologie
- MHATNP -Sv. Naum- EAD
- MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders
- Montreal Neurological Institute & Hospital
- Bispebjerg Hospital
- Tartu University Hospital
- CHU de Nîmes - Hôpital Caremeau
- Praxis Dr. med. Christian Oehlwein
- Charite - Campus Virchow- Klinikum, Klinik fur Neurologie
- Tel Aviv Sourasky Medical Center
- Ospedaliera Santa Maria Terni
- Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
- UO Farmacia Centralizzata OM (SC) Ospedale Maggiore
- Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia
- Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
- AOU San Giovanni di Dio e Ruggi d'Aragona
- New Zealand Brain Research Institute
- Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
- Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
- Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.
- Neuro-Care Sp. z o.o. sp. Komandytowa
- ETG Warszawa
- Specjalistyczn.e Gabinety Sp. Z o.o.
- Campus Neurologico Senior
- Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
- Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
- SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF
- Limited Liability Company City Neurological Center Sibneiromed
- State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34
- FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation
- Hospital del Mar
- Hospital de Cruces
- Hospital Universitario de La Princesa
- Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine
- Lviv Regional Clinical Hospital
- CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
- The National Hospital for Neurology & Neurosurgery
- Re:Cognition Health Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ampreloxetine
Arm Description
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04095793
Brief Title
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Acronym
OAK
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ampreloxetine
Arm Type
Experimental
Arm Description
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
Intervention Type
Drug
Intervention Name(s)
ampreloxetine
Other Intervention Name(s)
TD-9855
Intervention Description
Oral tablet, QD
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Day 1 up to a maximum of 749 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Neurostudies, Inc.
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
NorthShore University HealthSystem
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Cincinnati Medical Center (UCGNI)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Inland Northwest Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Concord Hospital, Neurosciences Department
City
Concord
State/Province
New South Wales
ZIP/Postal Code
02139
Country
Australia
Facility Name
Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Perron Institute for Neurological and Translational Science
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
06009
Country
Australia
Facility Name
Universitätsklinikum Tulln Abteilung fur Neurologie
City
Tulln
ZIP/Postal Code
3430
Country
Austria
Facility Name
MHATNP -Sv. Naum- EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Montreal Neurological Institute & Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
CHU de Nîmes - Hôpital Caremeau
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
Praxis Dr. med. Christian Oehlwein
City
Gera
State/Province
Thueringen
ZIP/Postal Code
7551
Country
Germany
Facility Name
Charite - Campus Virchow- Klinikum, Klinik fur Neurologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Ospedaliera Santa Maria Terni
City
Terni
State/Province
Umbria
ZIP/Postal Code
5100
Country
Italy
Facility Name
Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
UO Farmacia Centralizzata OM (SC) Ospedale Maggiore
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
AOU San Giovanni di Dio e Ruggi d'Aragona
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Facility Name
New Zealand Brain Research Institute
City
Christchurch
ZIP/Postal Code
08011
Country
New Zealand
Facility Name
Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
City
Katowice
ZIP/Postal Code
40588
Country
Poland
Facility Name
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Neuro-Care Sp. z o.o. sp. Komandytowa
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
ETG Warszawa
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Specjalistyczn.e Gabinety Sp. Z o.o.
City
Warszawa
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Campus Neurologico Senior
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal
Facility Name
Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
City
Krasnoyarsk
ZIP/Postal Code
660049
Country
Russian Federation
Facility Name
SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Limited Liability Company City Neurological Center Sibneiromed
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital de Cruces
City
Bilbao
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine
City
Kharkiv
ZIP/Postal Code
61172
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
The National Hospital for Neurology & Neurosurgery
City
London
State/Province
Greater London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Re:Cognition Health Ltd
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Learn more about this trial
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
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