Actively Recruiting
A Study in Subjects With Neurogenic Orthostatic Hypotension
Led by CuraSen Therapeutics, Inc. · Updated on 2026-05-05
12
Participants Needed
5
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).
CONDITIONS
Official Title
A Study in Subjects With Neurogenic Orthostatic Hypotension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 18 to 85 years old at time of informed consent
- Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease or pure autonomic failure
- At screening, a decrease of 20 mm Hg or more in systolic or 10 mm Hg or more in diastolic blood pressure upon standing for 3 minutes from supine position
- At screening, score of 4 or higher on Orthostatic Hypotension Symptom Assessment question #1
- Currently receiving or responsive to direct or indirect alpha1-adrenergic receptor agonists for treatment of neurogenic orthostatic hypotension
- If required, able to perform Valsalva maneuver to confirm autonomic dysfunction
- Body weight 50 kg or more and BMI between 18 and 35 inclusive at screening
- Stable medical conditions for at least 3 months prior to screening
- For patients on antiparkinsonian medication, stable dose for at least 1 month
- Ambulatory with or without an assistive device
- Willing to follow protocol and comply with study restrictions
- Capable of informed consent and complying with study procedures
- Able to speak, understand, and read English
You will not qualify if you...
- Systemic illnesses causing autonomic neuropathy such as diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, autoimmune neuropathies
- Use of vasoconstricting agents like ephedrine, dihydroergotamine, or midodrine must stop at least 1 day or 5 half-lives before dosing and during study
- Fludrocortisone use limited to stable dose of 0.1 mg once daily
- Supine systolic blood pressure 170 mm Hg or higher or seated systolic blood pressure 140 mm Hg or higher at screening
- Clinically meaningful urinary retention using or likely to use alpha1-adrenergic receptor antagonists or other specified medications
- Use of antihypertensive medications for essential hypertension unrelated to autonomic dysfunction
- Significant or unstable clinical disorders or lab abnormalities making investigational drug unsuitable
- History of malignant disease within 5 years except fully excised basal or squamous cell carcinoma or low-grade prostate adenocarcinoma
- Any significant illness apart from neurodegenerative disease per medical and clinical assessments
- History of severe depression or suicidal ideation
- Abnormal ECG findings including prolonged QTc or low heart rate
- Estimated glomerular filtration rate below 60 mL/min/1.73m2
- Use of prohibited medications during screening or study without approval
- Prior investigational drug treatment within 90 days or current participation in other treatment studies
- Known or suspected alcohol or substance abuse within past 12 months
- Positive screening for HIV, hepatitis C antibody, or current hepatitis B infection
- Females who are breastfeeding
- Any other reasons investigator deems participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
CuraSen Investigational Site
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
CuraSen Investigational Site
Farmington Hills, Michigan, United States, 48334
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3
CuraSen Investigational Site
Eatontown, New Jersey, United States, 07724
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4
CuraSen Investigational Site
New York, New York, United States, 10019
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5
CuraSen Investigational Site
Nashville, Tennessee, United States, 37240
Actively Recruiting
Research Team
C
Chief Medical Officer
CONTACT
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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