Phase 3 Open-Label Extension Study of TD-9855 for Treating symptomaticnOH in Subjects with Primary Autonomic Failure
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
- Registration Number
- EUCTR2019-002425-30-GB
- Lead Sponsor
- Theravance Biopharma Ireland Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
1. Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with TD-9855.
2. 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).
3. 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 71
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49
1. Subjects may not be enrolled in another clinical trial, with the exception of purely observational studies, which are allowed.
2. 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.
3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
4. Hypersensitivity to TD-9855 or the formulation excipients.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method