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

NCT04095793 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: 01712019-002425-30
• Study Type: interventional
• Target: 110
• Locations: 16 countries
• Sites: 51

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 up to a maximum of 749 days

Study Arms (1)

ampreloxetine

EXPERIMENTAL

Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.

Drug: ampreloxetine

Interventions

ampreloxetine DRUG

Oral tablet, QD

Also known as: TD-9855

ampreloxetine

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (55)

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Neurostudies, Inc.

Port Charlotte, Florida, 33952, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NorthShore University HealthSystem

Glenview, Illinois, 60026, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

University of Cincinnati Medical Center (UCGNI)

Cincinnati, Ohio, 45219, United States

Location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Concord Hospital, Neurosciences Department

Concord, New South Wales, 02139, Australia

Location

Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, 06009, Australia

Location

Universitätsklinikum Tulln Abteilung fur Neurologie

Tulln, 3430, Austria

Location

MHATNP -Sv. Naum- EAD

Sofia, 1113, Bulgaria

Location

MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders

Sofia, 1113, Bulgaria

Location

Montreal Neurological Institute & Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Tartu University Hospital

Tartu, 50406, Estonia

Location

CHU de Nîmes - Hôpital Caremeau

Nîmes, Gard, 30029, France

Location

Praxis Dr. med. Christian Oehlwein

Gera, Thuringia, 7551, Germany

Location

Charite - Campus Virchow- Klinikum, Klinik fur Neurologie

Berlin, 13353, Germany

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Ospedaliera Santa Maria Terni

Terni, Umbria, 5100, Italy

Location

Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria

Bologna, 40139, Italy

Location

UO Farmacia Centralizzata OM (SC) Ospedale Maggiore

Bologna, 40139, Italy

Location

Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia

Milan, 20122, Italy

Location

Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia

Roma, 00133, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento

Roma, 00168, Italy

Location

AOU San Giovanni di Dio e Ruggi d'Aragona

Salerno, 84131, Italy

Location

New Zealand Brain Research Institute

Christchurch, 08011, New Zealand

Location

Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala

Katowice, 40588, Poland

Location

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej

Krakow, 31-505, Poland

Location

Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.

Oświęcim, 32-600, Poland

Location

Neuro-Care Sp. z o.o. sp. Komandytowa

Siemianowice Śląskie, 41-100, Poland

Location

ETG Warszawa

Warsaw, 02-793, Poland

Location

Specjalistyczn.e Gabinety Sp. Z o.o.

Warsaw, 30-539, Poland

Location

Campus Neurologico Senior

Torres Vedras, 2560-280, Portugal

Location

Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency

Krasnoyarsk, 660037, Russia

Location

Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency

Krasnoyarsk, 660049, Russia

Location

SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF

Moscow, 125284, Russia

Location

Limited Liability Company City Neurological Center Sibneiromed

Novosibirsk, 630091, Russia

Location

State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34

Novosibirsk, 630091, Russia

Location

FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation

Saint Petersburg, 192019, Russia

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital de Cruces

Bilbao, 48903, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine

Kharkiv, 61172, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, 79010, Ukraine

Location

CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology

Vinnytsia, 21005, Ukraine

Location

The National Hospital for Neurology & Neurosurgery

London, Greater London, WC1N 3BG, United Kingdom

Location

Re:Cognition Health Ltd

London, W1G 9JF, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Pure Autonomic Failure; Hypotension, Orthostatic; Hypotension; Dizziness; Syncope

Interventions

ampreloxetine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations

Limitations and Caveats

Because the study was terminated early by the Sponsor, the latest scheduled study visit completed by any participant was at Week 98.

Results Point of Contact

• Title: Medical Monitor
• Organization: Theravance Biopharma

medinfo@theravance.com

855 633 8479

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: September 19, 2019
• Study Start: September 19, 2019
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: November 30, 2022
• Results First Posted: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); NZ (1); BU (2); ES (1); RU (6); PT (1); UA (3); AU (3); PL (6); FR (1); GB (2); IT (7); US (13); DE (2); IL (1); DK (1)