A phase 3, 22-week, multi-center (61 locations), randomized withdrawal study of TD-9855 in treating symptomatic neurogenic orthostatic hypotension in subjects with primary autonomic failure

Theravance Biopharma
Study Design: 
REDWOOD consists of three phases. It starts with 16 weeks of open-label (OL) treatment, then a six-week randomized placebo-controlled treatment phase, and finally a two-week follow-up which is only for patients who do not enroll in OAK, a long-term extension safety study. The blinding for the second phase is quadruple (participant, care provider, investigator, and outcomes assessor). Participants in the SEQUOIA study are eligible to enter REDWOOD. In addition, the trial is recruiting de novo patients.
The primary outcome measure is the change from baseline in the OHSA question #1 score of one point and worsening of disease severity as assessed by a one-point change in Patient Global Impression of Severity (PGI-S) at week six post randomisation (week 16 to week 22). The secondary outcome measures, all assessed at week six post-randomization (week 16 to week 22), are: 1. Change from baseline in OHSA#1; 2. Change from baseline in OHSA composite score; 3. Change from baseline in OHDAS composite score; 4. Change from baseline in PGI-S; 5. Change from baseline in percent of time spent in standing position as measured by a wearable device that provides date- and time-stamped activity information to measure the time spent in supine, sitting, and standing positions; 6. Change from baseline in average number of steps taken as measured by a wearable device.