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

Stopped early · Phase 3

Conditions studied: Symptomatic Neurogenic Orthostatic Hypotension

In brief

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.

Key facts

Study ID

NCT04095793

Run by

Theravance Biopharma

People needed

110

Starts

2019-09-19

Expected to finish

2021-11-12

Last updated by the study team

2022-11-30

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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).
• 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.

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.

Where it is running

• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Neurostudies, Inc. — Port Charlotte, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• NorthShore University HealthSystem — Glenview, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• New York University School of Medicine — New York, New York, United States
• University of Cincinnati Medical Center (UCGNI) — Cincinnati, Ohio, United States
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Inland Northwest Research — Spokane, Washington, United States
• Concord Hospital, Neurosciences Department — Concord, New South Wales, Australia
• Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre — Clayton, Victoria, Australia
• Perron Institute for Neurological and Translational Science — Nedlands, Western Australia, Australia
• Universitätsklinikum Tulln Abteilung fur Neurologie — Tulln, Austria
• MHATNP -Sv. Naum- EAD — Sofia, Bulgaria
• MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders — Sofia, Bulgaria
• Montreal Neurological Institute & Hospital — Montreal, Quebec, Canada
• Bispebjerg Hospital — Copenhagen, Denmark
• Tartu University Hospital — Tartu, Estonia
• CHU de Nîmes - Hôpital Caremeau — Nîmes, Gard, France
• Praxis Dr. med. Christian Oehlwein — Gera, Thuringia, Germany
• Charite - Campus Virchow- Klinikum, Klinik fur Neurologie — Berlin, Germany
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States

Full record on ClinicalTrials.gov

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