A Study in Subjects With Neurogenic Orthostatic Hypotension
ConditionNeurogenic Orthostatic Hypotension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCuraSen Therapeutics, Inc.
About this trial
This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects ≥ 18 and ≤ 85 years of age, at time of informed consent.
Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease or pure autonomic failure (i.e. neurogenic orthostatic hypotension).
At Screening, subjects must meet the diagnostic criteria of neurogenic orthostatic hypotension, as demonstrated by a decrease ≥20 mm Hg in systolic or ≥10 mm Hg in diastolic BP upon standing ≤3 minutes from a supine position.
At Screening, subjects must have a score ≥4 on the Orthostatic Hypotension Symptom Assessment (OHSA) scale question #1.
Disqualifiers
Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.
Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure (BP) such as ephedrine, dihydroergotamine, or midodrine must be stopped at least 1 day or 5 half-lives (whichever is longer) prior to dosing on Day 1 and throughout the duration of the study. Fludrocortisone use in the study will be limited to a stable dose of 0.1 mg once-daily (QD).
Supine SBP ≥ 170 mm Hg or seated SBP ≥ 140 mm Hg at Screening.
Subjects with clinically meaningful urinary retention who use or are likely to use α1-AR antagonists (e.g., tamsulosin [Flomax]), or other medications (e.g., trazodone).
Trial design
Design model
Sequential
Treatments tested in this trial
CST-3056
DrugAdministered as an oral solution
Placebo
DrugAdministered as an oral solution
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: CST-3056Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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 4Secondary outcomes
1
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 42
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 43
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov