Blood Pressure (TD-9855, Ampreloxetine)

What’s it about?
For some people Parkinson’s can cause a sustained drop in blood pressure when you stand up, change position or stand for a long period. Your symptoms could include dizziness, lightheadedness, and the feeling that you are about to black out. The medical term is “symptomatic neurogenic orthostatic hypotension” or snOH for short.

This is a large-scale Phase 3 Clinical Research study of a drug called TD-9855 (trade name Ampreloxetine) for the treatment of snOH.  It is not a cure.  “Phase 3” means that it has already been given to a smaller group of people with your condition and to people with attention‑deficit hyperactivity disorder (ADHD) and fibromyalgia. In this study, it is being tested in nearly 200 people with snOH and Parkinson’s, Multiple Systems Atrophy or Pure Autonomic Failure.

This Trial is open  for recruitment (1/10/2020).

What is the objective?
This study is looking at whether TD-9855 works, how safe it is, and at the effects on your general wellbeing. A person who cares for you may also take part and give information on their experiences of caring for you. The drug is being compared with a placebo, so you would have a 50/50 chance of receiving either TD-9855 or the placebo.

Where is it?
The local study centres are at the Royal Devon & Exeter Hospital, Exeter and at Derriford Hospital, Plymouth.

What does it involve?
This clinical research study is split into a screening period, treatment period, and a follow-up period. You would be in the study for up to 8 weeks and must attend 7 study visits in total. The drug or placebo is one daily pill. The full details are in this Patient Participation Leaflet

Who is eligible?
You must be at least 30 years of age and have snOH.

How do I enrol?
Go to Re;Cognition Health’s Parkinson’s page and complete the Enquiry Form or call 01752 712046.

Who is conducting the Study?
The study is sponsored by the drug patent’s owner, Theravance Biopharma Ireland Limited. The study is being managed for them by Re:Cognition Health.