Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension
- Interventions
- Registration Number
- NCT04095793
- Lead Sponsor
- Theravance Biopharma
- Brief Summary
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.
- Detailed Description
This is 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. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ampreloxetine ampreloxetine Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) Day 1 up to a maximum of 749 days An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period.
Clinically significant abnormalities in physical and neurological examinations, vital signs, resting 12-lead electrocardiograms, and clinical laboratory evaluations, in addition to incidence of fall, suicidal ideation, and suicidal behavior, were reported as AEs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (55)
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
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
Scroll for more (45 remaining)Colorado Springs Neurological Associates🇺🇸Colorado Springs, Colorado, United States