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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
Led by CuraSen Therapeutics, Inc. · Updated on 2026-05-05
12
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of CST-3056 on symptoms and signs of neurogenic orthostatic hypotension nOH, a condition causing low blood pressure upon standing. This Phase 2 study focuses on subjects diagnosed with nOH due to Parkinsons disease or pure autonomic failure. The trial aims to better understand how CST-3056 affects orthostatic symptoms compared to placebo under medical supervision. Participants will receive single oral doses of CST-3056 once daily for five days, including three initial dosing days and an Optimal Dose Day determined by monitoring blood pressure and tolerability. Some days include a single dose of placebo for comparison. Before dosing, subjects must stop other similar medications for at least one day or five half-lives. After inpatient dosing, participants will be contacted by phone within a week to check on their health and report any side effects. During the study, participants will undergo assessments of standing and seated blood pressure at multiple times after dosing. They will also have symptom evaluations using the Orthostatic Hypotension Symptom Assessment and a heads-up tilt table test for blood pressure response on the Optimal Dose Day. Safety and tolerability will be monitored throughout. The study participation will last through the dosing days and follow-up call, with health status tracked after discharge.
CONDITIONS
Brief Title
A Study in Subjects With Neurogenic Orthostatic Hypotension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 to 85 years at the time of consent
- Diagnosed with symptomatic neurogenic orthostatic hypotension due to Parkinson's disease or pure autonomic failure
- At screening, must show a decrease of at least 20 mm Hg systolic or 10 mm Hg diastolic blood pressure upon standing within 3 minutes
- Score of 4 or higher on the Orthostatic Hypotension Symptom Assessment (OHSA) scale question #1 at screening
- Currently receiving or responsive to direct or indirect alpha1-adrenergic receptor agonists for nOH treatment
- Body weight at least 50 kg and body mass index between 18 and 35 kg/m2 at screening
- Stable medical conditions for at least 3 months prior to screening
- Stable dose of antiparkinsonian medication for at least 1 month if applicable
- Ambulatory with or without assistive devices
- Willing and able to comply with protocol requirements and provide informed consent
- Able to speak, understand, and read English
You will not qualify if you...
- Systemic illnesses causing autonomic neuropathy such as diabetes, amyloidosis, monoclonal gammopathy, or autoimmune neuropathies
- Use of vasoconstricting agents like ephedrine or dihydroergotamine must be stopped at least 1 day or 5 half-lives before dosing and during the study; fludrocortisone limited to stable 0.1 mg daily dose
- 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 with use or likely use of alpha1-adrenergic antagonists or other specified medications
- Use of antihypertensive medication for essential hypertension unrelated to autonomic dysfunction
- Significant or unstable clinical disorders or lab abnormalities that make investigational drug use unsuitable
- History of malignant disease within 5 years except certain skin cancers and low-grade prostate adenocarcinoma
- Clinically significant illness apart from neurodegenerative disease as determined by medical evaluations
- History of suicidal ideation or severe depression
- Abnormal ECG findings including prolonged QTcF intervals or low heart rate at screening
- Estimated glomerular filtration rate below 60 mL/min/1.73m2
- Use of prohibited prescription medications unless approved
- Prior investigational drug use within 90 days or enrollment in another interventional study
- Known or suspected substance or alcohol abuse within 12 months or positive drug tests at screening
- Positive tests for HIV, hepatitis C antibody, or current hepatitis B infection
- Females who are breastfeeding
- Any other reason judged by the investigator as unsuitable for participation
Research Team
C
Chief Medical Officer
M
Medical Monitor
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