A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Theravance Biopharma
- Enrollment
- 203
- Locations
- 82
- Primary Endpoint
- Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period
Study Overview
Brief Summary
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
Detailed Description
Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in efficacy and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH. The study consists of 3 periods: (i) 16-week open-label (OL) treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled treatment, and (iii) 2-week follow-up (only for patients who do not enroll in Study 0171 (long-term extension safety study)).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ampreloxetine (Open Label (OL))
Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 16 weeks.
Intervention: ampreloxetine (Drug)
ampreloxetine
After completing the OL, participants randomized to ampreloxetine will receive single, oral, daily dose of active drug for a further 6 weeks.
Intervention: ampreloxetine (Drug)
Placebo
After completing the OL, participants randomized to Placebo will receive single, oral, daily dose of placebo for 6 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period
Time Frame: 6-week randomized withdrawal period (Week 16 to Week 22)
Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity. Least squares mean here is the model-based proportion of participants with treatment failure using logistic regression.
Secondary Outcomes
No secondary outcomes reported