Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
Conditions
Interventions
Product Code: TD-9855
Pharmaceutical Form: Tablet
INN or Proposed INN: ampreloxetine hydrochloride
CAS Number: 1227056-84-9
Current Spon
Sponsors
Theravance Biopharma Ireland Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the long-term safety of TD-9855 over a 182-week period.;Secondary Objective: Not applicable; Primary end point(s): Primary safety and tolerability endpoints include: • Physical examination • Neurological examination • Vital signs • Resting ECGs • Clinical laboratory tests including biochemistry, hematology, and urinalysis. • Concomitant medication • AEs • Subject compliance to study treatment • Incidence of falls • Columbia Suicide Severity Rating Scale (C-SSRS) ; Timepoint(s) of evaluation of this end point: • Physical examination evaluated at visits 1,4, 6 • Neurological examination evaluated at visits 1,4, 6 • Vital signs evaluated at visits 1, 2, 3, 4, 5, 6 • Resting ECGs evaluated at visits 1, 4, 6 • Clinical laboratory tests including biochemistry, hematology, and urinalysis evaluated at visits 1, 4 and 6 • Concomitant medication evaluated at all visits and at telephone contacts • Subject compliance to study treatment evaluated at visits 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 • Incidence of falls evaluated at visits 1, 2, 3, 4, 5 and 6 • Columbia Suicide Severity Rating Scale (C-SSRS) evaluated at visits 1, 2, 3, 4, 5 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Australia, Austria, Bulgaria, Canada, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, New Zealand, Poland, Portugal, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactDr. Brett Haumann
Theravance Biopharma Ireland Limited
Outcome results
None listed