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

Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:30 - Any
Start Date:January 24, 2019
End Date:September 1, 2020
Contact:Theravance Biopharma Call Center

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A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

A Phase 3 study to evaluate efficacy, safety, and tolerability of TD-9855 in subjects with
primary autonomic failures (MSA, PD, or PAF) and snOH with up to 4 weeks of treatment.

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to
evaluate efficacy, safety, and tolerability of TD-9855 in subjects with primary autonomic
failures (MSA, PD, or PAF) and snOH. The study consists of 3 periods: (i) 2-week screening,
(ii) 4-week randomized treatment, and (iii) 2-week follow up.

Inclusion Criteria:

- Subject is male or female and at least 30 years old.

- Subject must meet the diagnostic criteria of snOH, as demonstrated by a ≥20 mm Hg
(systolic) or ≥10 mm Hg (diastolic) within 3 minutes of being tilted-up to ≥60o from a
supine position as determined by a tilt-table test.

- Subject must score at least a 4 on the Orthostatic Hypotension Symptom Assessment
Question #1 at randomization visit.

- For subjects with PD only: Subject has a diagnosis of PD according to the United
Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992).

- For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the
Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman
Criteria (2008).

- For subjects with PAF only: Subject has impaired autonomic reflexes, as determined by
absence of Phase IV BP overshoot after release of the Valsalva strain.

- Subject has plasma NE levels >100 pg/mL after being in seated position for 30 minutes.

Exclusion Criteria:

- Subject has a known systemic illness known to produce autonomic neuropathy, including
but not limited to diabetes mellitus, diabetes insipidus, diabetic neuropathy,
amyloidosis, and autoimmune neuropathies.

- Subject has a known intolerance to other NRIs or SNRIs.

- Subject currently uses concomitant antihypertensive medication for the treatment of
essential hypertension unrelated to autonomic dysfunction.

- Subject has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives,
whichever is longer, prior to randomization or requires concomitant use until the
follow-up visit.

- Subject has changed dose, frequency, or type of prescribed medication for orthostatic
hypotension (e.g., ephedrine, dihydroergotamine, or fludrocortisone), within 7 days
prior to randomization visit. These medications must be tapered off postrandomization.
Tapering will follow the product's United States (US) package insert. Midodrine and
droxidopa must be tapered off at least 7 days prior to randomization.

- Subject has a known or suspected alcohol or substance abuse within the past 12 months
(DSM-IV-TR® definition of alcohol or substance abuse).

- Subject has a clinically unstable coronary artery disease, or major cardiovascular or
neurological event in the past 6 months.

- Subject has used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to

- Subject has a history of untreated closed angle glaucoma, or treated closed angle
glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk
to the subject.

- Subject has any significant uncontrolled cardiac arrhythmia.

- Subject has a Montreal Cognitive Assessment (MoCA) ≤23.

- Subject had a myocardial infarction in the past 6 months or has current unstable

- Subject has known congestive heart failure (New York Heart Association [NYHA] Class 3
or 4).

- Subject has a clinically significant abnormal laboratory findings (e.g., alanine
aminotransferase [ALT] or aspartate aminotransferase [AST] >3.0 x upper limit of
normal [ULN]; blood bilirubin [total] >1.5 x ULN; estimated glomerular filtration rate
(eGFR) <30 mL/min/1.73m2, or any abnormal laboratory value that could interfere with
safety of the subject).

- Subject has demonstrated a history of lifetime suicidal ideation and/or suicidal
behavior, as outlined by the C-SSRS (Baseline/Screening Version) subject should be
assessed by the rater for risk of suicide and the subject's appropriateness for
inclusion in the study.
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