This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).
This is a study to evaluate the effects of CST-3056 on orthostatic symptoms in subjects with nOH. Subjects who use direct or indirect α1-AR agonists for treatment of nOH will need to discontinue those treatments for at least 1 day or 5 half-lives (whichever is longer) prior to assessment of orthostatic measures during Screening, and again prior to initiation of dosing for study drug on Day 1. Following confirmation of eligibility, subjects will be enrolled and participate in a single-blind dose ranging study. Single oral doses of CST-3056 will be administered once-daily for five days (Days 1 through 4 and the Optimal Dose Day \[Day 5\]), as tolerated. The Individual Optimal Dose will be determined based on observations for each subject over Day 1 through Day 4, including standing blood pressure, and safety/tolerability of the dose. Between 3-7 days after discharge from the in-patient stay, the Investigator or designee will contact the subject by telephone to review the subject's health status. Any adverse events reported by phone will be recorded and followed as medically appropriate as determined by the Investigator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
CuraSen Investigational Site
Farmington Hills, Michigan, United States
RECRUITINGCuraSen Investigational Site
Eatontown, New Jersey, United States
RECRUITINGCuraSen Investigational Site
New York, New York, United States
RECRUITINGChange from Baseline in Standing Systolic Blood Pressure
Baseline is defined as the pre-dose measurement on Day 1
Time frame: Baseline and 1, 2, 3, and 4 hours post-dose on Days 1 to 4
Change from Baseline in Seated Systolic Blood Pressure relative to placebo
Baseline is defined as the pre-dose measurement on Day 1
Time frame: Baseline and 5 minutes post-dose on Days 1 to 4
Change from Baseline in the Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 relative to placebo
The question asks subjects to rate the severity of their orthostatic hypotension symptoms (dizziness, lightheaded, feeling faint, or felling like you might black out) on an 11-point scale from 0-10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. A higher score indicates a worse outcome. Baseline is defined as the pre-dose measurement on Day 1.
Time frame: Baseline and 3 hours post-dose on Days 1 to 4
Change from Baseline in the heads-up tilt table test (HUTT)
Subjects will have blood pressure and heart rate measured continuously and/or intermittently after resting in the supine position and pre-dose measurements will be taken twice. After dosing, subjects will undergo a graded HUTT at 30, 45 and 60 degrees. Measurements will be taken continuously and/or intermittently and at 1 and 3 minutes after each degree of tilt.
Time frame: Baseline and 3 hours post-dose on Optimal Dose Day (Day 5)
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CuraSen Investigational Site
Nashville, Tennessee, United States
RECRUITING