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COMPLETED Phase 3

Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

NCT03750552 · View on ClinicalTrials.gov ↗

Study Summary

A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

Interventions

  • DRUG Placebo
  • DRUG ampreloxetine

Study Locations (20)

Florida

  • Parkinson's Disease and Movement Disorders Center — Boca Raton
  • SFM Clinical Research — Boca Raton
  • Fixel Institute for Neurological Diseases — Gainesville
  • Neurostudies, Inc — Port Charlotte

California

  • Collaborative Neuroscience Network, LLC — Long Beach
  • Stanford Neuroscience Health Center — Palo Alto

Colorado

  • Colorado Springs Neurological Associates, PC — Colorado Springs
  • University of Colorado Health — Loveland

Illinois

  • Rush University Medical Center — Chicago
  • NorthShore University Health System — Glenview

Ohio

  • University of Cincinnati Medical Center — Cincinnati
  • The Ohio State University Wexner Medical Center — Columbus

Arizona

  • Banner Sun Health Research Institute — Sun City

District of Columbia

  • Georgetown University Hospital, Dept. of Neurology — Washington D.C.

Kansas

  • University of Kansas Medical Center — Kansas City

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2019-01-24
Est. Completion 2021-07-21
Phase Phase 3

Sponsor

Theravance Biopharma

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03750552

The ClinicalTrials.gov registry entry for NCT03750552 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theravance Biopharma, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Symptomatic Neurogenic Orthostatic Hypotension appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03750552 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03750552 about?

NCT03750552 is a clinical study titled "Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure". A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

What is the current status of trial NCT03750552?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 195 participants. The study started on 2019-01-24. Estimated completion is 2021-07-21.

What conditions does trial NCT03750552 study?

This clinical trial studies the following conditions: Symptomatic Neurogenic Orthostatic Hypotension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03750552?

The interventions under investigation include: Placebo (DRUG), ampreloxetine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03750552?

This trial is sponsored by Theravance Biopharma, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03750552 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial