Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (OAK)

November 7, 2022 updated by: Theravance Biopharma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 02139
        • Concord Hospital, Neurosciences Department
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 06009
        • Perron Institute for Neurological and Translational Science
  • Austria
      • Tulln, Austria, 3430
        • Universitatsklinikum Tulln Abteilung fur Neurologie
  • Bulgaria
      • Sofia, Bulgaria, 1113
        • MHATNP -Sv. Naum- EAD
      • Sofia, Bulgaria, 1113
        • MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders
  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Institute & Hospital
  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
  • Estonia
      • Tartu, Estonia, 50406
        • Tartu University Hospital
  • France
    • Gard
      • Nîmes, Gard, France, 30029
        • CHU de Nîmes - Hôpital Caremeau
  • Germany
      • Berlin, Germany, 13353
        • Charite - Campus Virchow- Klinikum, Klinik fur Neurologie
    • Thueringen
      • Gera, Thueringen, Germany, 7551
        • Praxis Dr. Med. Christian Oehlwein
  • Israel
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40139
        • Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria
      • Bologna, Italy, 40139
        • UO Farmacia Centralizzata OM (SC) Ospedale Maggiore
      • Milano, Italy, 20122
        • Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento
      • Roma, Italy, 00133
        • Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia
      • Salerno, Italy, 84131
        • AOU San Giovanni di Dio e Ruggi d'Aragona
    • Umbria
      • Terni, Umbria, Italy, 5100
        • Ospedaliera Santa Maria Terni
  • New Zealand
      • Christchurch, New Zealand, 08011
        • New Zealand Brain Research Institute
  • Poland
      • Katowice, Poland, 40588
        • Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala
      • Kraków, Poland, 31-505
        • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
      • Oswiecim, Poland, 32-600
        • Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.
      • Siemianowice Śląskie, Poland, 41-100
        • Neuro-Care Sp. z o.o. Sp. Komandytowa
      • Warszawa, Poland, 02-793
        • Etg Warszawa
      • Warszawa, Poland, 30-539
        • Specjalistyczn.e Gabinety Sp. Z o.o.
  • Portugal
      • Torres Vedras, Portugal, 2560-280
        • Campus Neurologico Senior
  • Russian Federation
      • Krasnoyarsk, Russian Federation, 660037
        • Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
      • Krasnoyarsk, Russian Federation, 660049
        • Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency
      • Moscow, Russian Federation, 125284
        • SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF
      • Novosibirsk, Russian Federation, 630091
        • Limited Liability Company City Neurological Center Sibneiromed
      • Novosibirsk, Russian Federation, 630091
        • State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34
      • Saint Petersburg, Russian Federation, 192019
        • FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation
  • Spain
      • Barcelona, Spain, 8003
        • Hospital Del Mar
      • Bilbao, Spain, 48903
        • Hospital De Cruces
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
  • Ukraine
      • Kharkiv, Ukraine, 61172
        • Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine
      • Lviv, Ukraine, 79010
        • Lviv Regional Clinical Hospital
      • Vinnytsia, Ukraine, 21005
        • CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology
  • United Kingdom
      • London, United Kingdom, W1G 9JF
        • Re:Cognition Health Ltd
    • Greater London
      • London, Greater London, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Neurological Associates
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
      • Port Charlotte, Florida, United States, 33952
        • Neurostudies, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center (UCGNI)
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University (OHSU)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Washington
      • Spokane, Washington, United States, 99202
        • Inland Northwest Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ampreloxetine
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
Drug: ampreloxetine
Oral tablet, QD
Other Names:
  • TD-9855

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 up to a maximum of 749 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2019

Primary Completion (Actual)

November 12, 2021

Study Completion (Actual)

November 12, 2021

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0171
  • 2019-002425-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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