Status:
TERMINATED
Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Lead Sponsor:
Theravance Biopharma
Conditions:
Symptomatic Neurogenic Orthostatic Hypotension
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04095793
Start Date
September 19 2019
End Date
November 12 2021
Last Update
November 30 2022
Active Locations (55)
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1
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States, 80907
2
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
3
Neurostudies, Inc.
Port Charlotte, Florida, United States, 33952
4
Rush University Medical Center
Chicago, Illinois, United States, 60612