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NCT05696717 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy
A Phase 3 study of MSA - Multiple System Atrophy and Symptomatic Neurogenic Orthostatic Hypotension, sponsored by Theravance Biopharma.
- Active
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
- 20
- Study locations
NCT05696717: Active Phase 3 study of MSA - Multiple System Atrophy and Symptomatic Neurogenic Orthostatic Hypotension, sponsored by Theravance Biopharma.
NCT05696717 is a Phase 3 study of MSA - Multiple System Atrophy and Symptomatic Neurogenic Orthostatic Hypotension that is active but no longer recruiting, run by Theravance Biopharma. The registered enrollment target is 102 participants, below the 1,028-participant average among 3 other MSA - Multiple System Atrophy trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05696717, a Phase 3 study of MSA - Multiple System Atrophy and Symptomatic Neurogenic Orthostatic Hypotension, is active but no longer recruiting, sponsored by Theravance Biopharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).
Primary Outcome
Score change from baseline on the composite of Questions 1 - 6 of the Orthostatic Hypotension Symptom Assessment (OHSA).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ampreloxetine
Study Locations (20)
Florida
- Parkinson's Disease And Movement Disorders Center of Boca Raton - Boca Raton
- SFM Clinical Research, LLC - Boca Raton
- Aqualane Clinical Research - Naples
- Neurostudies, Inc - Port Charlotte
- University of South Florida Ataxia Research Center - Tampa
California
- The Parkinson's and Movement Disorder Institute - Fountain Valley
- UC San Diego Movement Disorder Center - La Jolla
- David Geffen School of Medicine at UCLA - Los Angeles
- Stanford Neuroscience Health Center - Palo Alto
Illinois
- Rush University Medical Center - Chicago
- Northshore University Health System - Glenview
Massachusetts
- Brigham and Women's Hospital (Neuromuscular Division) - Boston
- Massachusetts Chan Medical School - Worcester
Arizona
- Movement Disorders Center of Arizona - Scottsdale
District of Columbia
- Medstar Georgetown University Hospital - Washington D.C.
Georgia
- Emory University - Atlanta
Hawaii
- Hawaii Pacific Neuroscience - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
What the registry record for NCT05696717 still lists
NCT05696717 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,028-participant average among 3 other MSA - Multiple System Atrophy trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with MSA - Multiple System Atrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05696717 names 20 study sites across 11 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05696717 about?
NCT05696717 is a clinical study titled "Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy". This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extensi...
What is the current status of trial NCT05696717?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2023-06-27. Estimated completion is 2028-01.
What conditions does trial NCT05696717 study?
This clinical trial studies the following conditions: MSA - Multiple System Atrophy, Symptomatic Neurogenic Orthostatic Hypotension.
What interventions are being tested in trial NCT05696717?
The interventions under investigation include: Placebo (DRUG), Ampreloxetine (DRUG).
Who is sponsoring clinical trial NCT05696717?
This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05696717 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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