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NCT03750552 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Symptomatic Neurogenic Orthostatic Hypotension, sponsored by Theravance Biopharma.

Completed
Registry status
Phase 3
Development phase
195
Enrollment target
20
Study locations

NCT03750552 is a Phase 3 study of Symptomatic Neurogenic Orthostatic Hypotension that has completed, run by Theravance Biopharma. The registered enrollment target is 195 participants. The trial reports 20 study locations across 13 states.

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The verdict

NCT03750552, a Phase 3 study of Symptomatic Neurogenic Orthostatic Hypotension, has completed, sponsored by Theravance Biopharma.

COMPLETED
Registry status
Phase 3
Development phase
195 participants
Enrollment target
20
Study locations

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

38 total trials

What the Registry Record Tells You About NCT03750552

The ClinicalTrials.gov registry entry for NCT03750552 describes a study currently listed as completed, categorized as Phase 3. 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 38 total studies on file at ClinicalTrials.gov.

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.

NCT03750552 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, Colorado.

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.

What interventions are being tested in trial NCT03750552?

The interventions under investigation include: Placebo (DRUG), ampreloxetine (DRUG).

Who is sponsoring clinical trial NCT03750552?

This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.

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.

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

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