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The William Harvey Research Institute - Barts and The London

Theravance 169

Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure.

Trial objective
To evaluate the efficacy of TD-9855 in subjects with multiple system atrophy (MSA), Parkinson’s disease (PD), or pure autonomic failure (PAF) experiencing symptomatic neurogenic orthostatic hypotension (snOH) compared with placebo at Week 4, as measured by the change from baseline of the Orthostatic Hypotension Symptom Assessment (OHSA) Question 1 (OHSA#1) score.

Disease area
Multiple System Atrophy, Parkinson’s Disease and Primary Autonomic Failure

Status
Open to recruitment

CI/PI
Dr Manish Saxena (PI)

Sponsor
Theravance Biopharma

Funder
Theravance Biopharma

Study summary
This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF).

This is a Phase 3 study. This means that the study drug has already been given to a smaller group of people in other clinical research studies with snOH and other types of conditions including people with attention‑deficit hyperactivity disorder (ADHD) and fibromyalgia. In this study, it will be tested in a larger group of people with snOH and PD, MSA, or PAF.

Currently, there are limited treatment options available for this patient population, and no treatment options that demonstrate durability of effect. Preclinical and clinical studies have demonstrated a moderate increase in heart rate and blood pressure, suggesting that TD-9855 has the potential to provide a novel treatment option for snOH.

The study drug will be compared with a placebo, which looks the same as the study drug but does not contain any active ingredients. Participants will be randomly assigned (by chance) and will have a 50/50 chance of receiving either the study drug (10 mg per day) OR placebo. Participants will take a single tablet of the study medication (study

drug or placebo) by mouth at the same time each morning with a glass of water. The study medication can be taken with or without food.

This study is ‘double-blinded’, which means that neither the participant nor the study doctor will know which study medication the participant taking.

The study will also collect information on the experiences of the person caring for the participant. If applicable, the person who cares for the participant (‘caregiver’) will be asked to complete a questionnaire about how caring for the participant affects their life.

Sample size and duration
188; approximately 8 weeks.

Enquiries  
Dr Manish Saxena: m.saxena@qmul.ac.uk
Armida Balawon: a.balawon@qmul.ac.uk