0171 Extension Study of TD-9855
Research type
Research Study
Full title
A Phase 3, 182-week, Open-Label, Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic Failure
IRAS ID
272508
Contact name
Camille Carroll
Contact email
Sponsor organisation
Theravance Biopharma Inc
Eudract number
2019-002425-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF).
It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH).
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 the condition 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.
Participants can enter this study if they have completed study 0170 (Phase 3, 22-week, Multicentre, Randomised Withdrawal Study of TD˗9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure)
Approximately 80 subjects are anticipated to enrol in Study 0171.
In this study, participants will receive treatment once daily for 182 weeks. Safety assessments of the treatment will be carried out periodically throughout the treatment period and for up to two weeks after the final treatment.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0026
Date of REC Opinion
17 Mar 2020
REC opinion
Further Information Favourable Opinion