Symptomatic Neurogenic Orthostatic HypotensionPhase 3OAKNCT04095793
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3 study testing ampreloxetine in people with Symptomatic Neurogenic Orthostatic Hypotension, run by Theravance Biopharma at 55 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Symptomatic Neurogenic Orthostatic Hypotension
- What is being tested?
- ampreloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 55 sitesin 18 countries
- Study dates
- 19 Sep 2019to 12 Nov 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
55 sites in 18 countries.
55 sites in 18 countries
United States13 sites
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati Medical Center (UCGNI)
Cincinnati, Ohio, 45219
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
NorthShore University HealthSystem
Glenview, Illinois, 60026
University of Kansas Medical Center
Kansas City, Kansas, 66160
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York University School of Medicine
New York, New York, 10016
Neurostudies, Inc.
Port Charlotte, Florida, 33952
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Inland Northwest Research
Spokane, Washington, 99202
Italy7 sites
Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
Bologna, 40139
UO Farmacia Centralizzata OM (SC) Ospedale Maggiore
Bologna, 40139
Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia
Milan, 20122
Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia
Roma, 00133
Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
Roma, 00168
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno, 84131
Ospedaliera Santa Maria Terni
Terni, Umbria, 5100
Poland6 sites
Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
Katowice, 40588
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
Krakow, 31-505
Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.
Oświęcim, 32-600
Neuro-Care Sp. z o.o. sp. Komandytowa
Siemianowice Śląskie, 41-100
ETG Warszawa
Warsaw, 02-793
Specjalistyczn.e Gabinety Sp. Z o.o.
Warsaw, 30-539
Russia6 sites
Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
Krasnoyarsk, 660037
Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
Krasnoyarsk, 660049
SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF
Moscow, 125284
Limited Liability Company City Neurological Center Sibneiromed
Novosibirsk, 630091
State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34
Novosibirsk, 630091
FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation
Saint Petersburg, 192019
Australia3 sites
Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre
Clayton, Victoria, 3168
Concord Hospital, Neurosciences Department
Concord, New South Wales, 02139
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, 06009
Spain3 sites
Hospital del Mar
Barcelona, 8003
Hospital de Cruces
Bilbao, 48903
Hospital Universitario de La Princesa
Madrid, 28006
Ukraine3 sites
Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine
Kharkiv, 61172
Lviv Regional Clinical Hospital
Lviv, 79010
CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
Vinnytsia, 21005
Bulgaria2 sites
MHATNP -Sv. Naum- EAD
Sofia, 1113
MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders
Sofia, 1113
Germany2 sites
Charite - Campus Virchow- Klinikum, Klinik fur Neurologie
Berlin, 13353
Praxis Dr. med. Christian Oehlwein
Gera, Thuringia, 7551
United Kingdom2 sites
The National Hospital for Neurology & Neurosurgery
London, Greater London, WC1N 3BG
Re:Cognition Health Ltd
London, W1G 9JF
Canada1 site
Montreal Neurological Institute & Hospital
Montreal, Quebec, H3A 2B4
New Zealand1 site
New Zealand Brain Research Institute
Christchurch, 08011
About this study
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
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.
Read the 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.
- Being tested
- ampreloxetine
- 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
- Medical subject headings
- Parkinson Disease, Pure Autonomic Failure, Hypotension, Orthostatic, Hypotension, Dizziness, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ampreloxetineDrug
Also called TD-9855
Oral tablet, QD
| Study group | Role | What they receive |
|---|---|---|
| ampreloxetine | Experimental | Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks. Receives: Drug: ampreloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 up to a maximum of 749 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start19 Sep 2019
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Why it stopped: Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptomatic Neurogenic Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095793
- Sponsor's protocol ID
- 0171
- Other IDs
- 2019-002425-30, 2019
- Acronym
- OAK
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2019
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04095793
- Acronym / sponsor ID
- OAK / 0171
- Keywords
- Symptomatic Neurogenic Orthostatic Hypotension, sympomatic nOH, multiple symptom atrophy, MSA, Parkinson's disease, PD, pure autonomic failure, PAF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ampreloxetine | Experimental | Drug: ampreloxetineParticipants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ampreloxetineAlso: TD-9855Oral tablet, QD | Drug | ampreloxetine |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Related trials for Symptomatic Neurogenic Orthostatic Hypotension
Active, not recruitingPhase 3
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy
Symptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Theravance Biopharma
55 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ampreloxetine in people with Symptomatic Neurogenic Orthostatic Hypotension, run by Theravance Biopharma at 55 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Italy, Poland, Russia, Australia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 up to a maximum of 749 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.