Neurogenic Orthostatic Hypotension (NOH)

0169

A Phase 3 Clinical Effect Study of TD-9855 for Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic Failure

Description
This 4-week placebo-controlled study is intended to evaluate the effectiveness of an investigational drug (TD-9855) in subjects with multiple system atrophy (MSA), Parkinson’s disease (PD), or pure autonomic failure (PAF) who are experiencing symptomatic neurogenic orthostatic hypotension (snOH) compared with placebo.

Currently enrolling

Who may be eligible to participate?
Subjects 30 years of age and older with a confirmed diagnosis of snOH due to MSA, PD, or PAF. Other inclusion and exclusion criteria may apply.

What does participation involve?
The total study duration per subject is approximately 9 weeks. After a 3-week screening period, subjects will be randomized to receive either TD-9855 or matching placebo once daily for the next 4 weeks.

Investigator: Alida Griffith, MD, Booth Gardner Parkinson’s Care Center

For More Information: contact the EvergreenHealth Research Services main line at 425.899.5385 or email EvergreenResearch@evergreenhealth.com.

0170

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

Description
This randomized withdrawal study aims to evaluate the sustained benefit in effectiveness and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or PAF) and snOH.

Currently enrolling

Who may be eligible to participate?
Subjects 30 years of age and older with a confirmed diagnosis of snOH due to MSA, PD, or PAF. Other inclusion and exclusion criteria may apply.

What does participation involve?
The total study duration per subject is approximately 22-24 weeks. The study consists of 3 periods: (i) 16-week open-label (OL) study treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled study treatment, and (iii) 2-week follow-up [only for subjects who do not enroll in Study 0171 (long-term extension safety study)].

Investigator: Alida Griffith, MD, Booth Gardner Parkinson’s Care Center

For More Information: contact the EvergreenHealth Research Services main line at 425.899.5385 or email EvergreenResearch@evergreenhealth.com.

RESTORE

A Clinical Study of Patients with Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy.

ClinicalTrials.gov Identifier: NCT02586623

Who may be eligible to participate?
Male and female subjects aged 18 years and older. Must be able to stand (with or without assistance). Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA or PAF) or NDAN or DBH Deficiency.

Investigator: Alida Griffith, MD

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com.