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
Qualifiers
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
Treatments tested in this trial
- CST-3056
- Placebo
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov