RecruitingPhase 2

A Study in Subjects With Neurogenic Orthostatic Hypotension

United States12 participantsStarted 2025-09-12

Plain-language summary

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

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).
✕. Concomitant use of anti-hypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.
✕. Evidence of any significant or unstable clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine (excluding managed hypo and hyperthyroidism), metabolic, renal, or other systemic disease or laboratory abnormality.
✕. History of malignant disease within 5 years, including solid tumors and hematologic malignancies (except \[a\] basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured; \[b\] low-grade adenocarcinoma of the prostate).
✕. Any clinically significant illness or disease (apart from those typically associated with neurodegenerative disease) as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments conducted at Screening.

What they're measuring

Change from Baseline in Standing Systolic Blood Pressure

Timeframe: Baseline and 1, 2, 3, and 4 hours post-dose on Days 1 to 4

Trial details

NCT IDNCT07089043

SponsorCuraSen Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-31

Contact for this trial

Chief Medical Officer

650-475-2842 info@curasen.com

View on ClinicalTrials.gov More Neurogenic Orthostatic Hypotension trials