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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

• Currently receiving, or known to be responsive to, direct or indirect α1-AR agonists (e.g., midodrine, droxidopa) for treatment of nOH.

• If the Investigator determines that additional autonomic function testing is required to confirm the diagnosis of autonomic dysfunction, the Valsalva maneuver may be performed to show the absence of BP overshoot during phase IV.

• Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg/m2, inclusive at Screening.

• Stable medical conditions for 3 months prior to Screening.

• For patients taking antiparkinsonian medication: stable dose of levodopa, dopamine agonist, amantadine, and/or monoamine oxidase B inhibitor, i.e. unchanged for 1 month.

⁃ Subject is ambulatory with/without the use of an assistive device.

⁃ Willing to follow the protocol requirements and comply with protocol restrictions.

⁃ Capable of providing informed consent and complying with study procedures.

⁃ Able to speak, understand, and read English.

Locations
United States
New Jersey
CuraSen Investigational Site
RECRUITING
Eatontown
New York
CuraSen Investigational Site
RECRUITING
New York
Tennessee
CuraSen Investigational Site
RECRUITING
Nashville
Contact Information
Primary
Chief Medical Officer
info@curasen.com
650-475-2842
Backup
Medical Monitor
info@curasen.com
650-475-2842
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 12
Treatments
Experimental: CST-3056
Subjects will receive single doses of CST-3056 over 3 days and on the Optimal Dose Day (Day 5)
Placebo_comparator: Placebo
Subjects will receive a single dose of placebo on 1 day
Sponsors
Leads: CuraSen Therapeutics, Inc.

This content was sourced from clinicaltrials.gov