A Single-Blind Dose-Ranging Study in Subjects With Neurogenic Orthostatic Hypotension to Evaluate the Effect of CST-3056 on Symptoms and Signs of Orthostatic Hypotension
CuraSen Therapeutics, Inc.
Summary
This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).
Description
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…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subjects ≥ 18 and ≤ 85 years of age, at time of informed consent. 2. Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease or pure autonomic failure (i.e. neurogenic orthostatic hypotension). 3. 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. 4. At Screening, subjects must have a score ≥4 on the Orthostatic Hypotension Symptom Assessment (OHSA) scale questi…
Interventions
- DrugCST-3056
Administered as an oral solution
- DrugPlacebo
Administered as an oral solution
Locations (5)
- CuraSen Investigational SiteScottsdale, Arizona
- CuraSen Investigational SiteFarmington Hills, Michigan
- CuraSen Investigational SiteEatontown, New Jersey
- CuraSen Investigational SiteNew York, New York
- CuraSen Investigational SiteNashville, Tennessee