Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Symptomatic Neurogenic Orthostatic Hypotension, sponsored by Theravance Biopharma.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
OHSA is an assessment of the severity of symptoms from low blood pressure. OHSA is a 6 question symptom assessment scale where each question uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. A mean negative change from baseline indicates a better outcome.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2021-07-21 |
| Phase | Phase 3 |
What the finished NCT03750552 record still lists
NCT03750552 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Symptomatic Neurogenic Orthostatic Hypotension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03750552's enrollment target sits among peer trials
195 1393rd of 2000 higher than 606 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04276922 · 195 participants · NA
Creative Arts Program to Reduce Burnout in Healthcare Professionals
- NCT04829357 · 195 participants
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
- NCT05054738 · 195 participants · NA
CRP and S&A for Inpatient Veterans
- NCT05561595 · 195 participants · NA
Transdiagnostic Intervention to Reduce Internalized Health-Related Stigma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI