Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Theravance Biopharma
Enrollment:
188
Study Design:
Participants will be randomized to receive a single oral daily dose of ampreloxetine or placebo. Blinding will be for the investigator, participant, care provider and outcome assessor. There are three phases, a four-week screening, four weeks of randomized treatment and a two week follow up. Apart from the screening visit, the required visits can be conducted either in clinic or remotely.
Rationale:
The primary outcome measure is the change from baseline in Orthostatic Hyp-otension Symptom Assessment (OHSA) question #1 at week 4. Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout. The timeframe is baseline to week 4. The secondary outcome measures are: 1. Change from baseline in OHSA composite score in weeks 1 to 4 (timeframe: baseline, week 1, week 2, week 3, week 4); 2. Change from baseline in Orthostatic Hypotension Daily Activities Scale (OHDAS) composite score in weeks 1 to 4 (timeframe: baseline, week 1, week 2, week 3, week 4). OHDAS is an assessment of how low blood pressure symptoms affect daily life; 3. Using the Patient Global Impression of Change (PGI-C) scale, a subject rates their total improvement at week 4 compared to baseline; 4. Incidence of patient-reported falls at week 4.
