CST-3056 for Neurogenic Orthostatic Hypotension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called CST-3056, a potential drug for people with neurogenic orthostatic hypotension (nOH). This condition causes dizziness or fainting when standing due to low blood pressure. Participants will receive either CST-3056 or a placebo to determine if the treatment improves symptoms. This trial suits those with nOH linked to Parkinson’s disease or pure autonomic failure who frequently experience dizziness when standing. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, like vasoconstricting agents such as ephedrine or midodrine, at least 1 day or 5 half-lives before starting the trial and throughout its duration. However, you can continue taking a stable dose of fludrocortisone and antiparkinsonian medications if they have been stable for at least 1 month.
Is there any evidence suggesting that CST-3056 is likely to be safe for humans?
Research has shown that CST-3056 was safe in earlier studies. In a previous study, participants tolerated CST-3056 well, with no major safety issues reported. This treatment is now in a Phase 2 trial, indicating some early evidence of safety, but researchers aim to confirm these results with a larger group. Although more information is needed to fully understand its safety, reaching this phase suggests it hasn't shown serious safety problems so far.12345
Why do researchers think this study treatment might be promising for neurogenic orthostatic hypotension?
CST-3056 is unique because it takes a fresh approach to treating neurogenic orthostatic hypotension (nOH). While most treatments for nOH focus on increasing blood volume or vasoconstriction, CST-3056 stands out by potentially offering a rapid response, showing effectiveness in just a few days. Researchers are excited about CST-3056 because it could provide faster symptom relief compared to existing options, which often require a longer duration to see results. Additionally, the possibility of optimizing the dosage over a short period could lead to more personalized and effective treatment strategies for individuals with nOH.
What evidence suggests that CST-3056 might be an effective treatment for neurogenic orthostatic hypotension?
Research has shown that CST-3056, which participants in this trial may receive, might help people with neurogenic orthostatic hypotension (nOH) by improving their blood pressure when they stand up. Studies indicate it can prevent severe drops in blood pressure, a common issue for those with nOH. Early testing suggested that the treatment is safe, supporting further research. CST-3056 aims to keep blood pressure steady and reduce symptoms like dizziness or lightheadedness when changing positions. Initial results are promising, but more research is needed to confirm its effectiveness.36789
Who Is on the Research Team?
Chief Medical Officer
Principal Investigator
CuraSen Therapeutics, Inc.
Are You a Good Fit for This Trial?
Adults aged 18-85 with neurogenic orthostatic hypotension (nOH) due to Parkinson's disease or pure autonomic failure, who are responsive to α1-AR agonists like midodrine. Participants must have stable medication doses and medical conditions, not use certain blood pressure medications, and have a BMI between 18 and 35 kg/m2.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single oral doses of CST-3056 once daily for five days, with dose optimization based on observations
Follow-up
Participants are contacted by phone to review health status and report any adverse events
What Are the Treatments Tested in This Trial?
Interventions
- CST-3056
Trial Overview
The trial is testing CST-3056 against a placebo to see if it improves symptoms of nOH. Patients will be randomly assigned to receive either the investigational drug or a placebo for comparison.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Subjects will receive single doses of CST-3056 over 3 days and on the Optimal Dose Day (Day 5)
Subjects will receive a single dose of placebo on 1 day
Find a Clinic Near You
Who Is Running the Clinical Trial?
CuraSen Therapeutics, Inc.
Lead Sponsor
Citations
CuraSen Therapeutics Doses First Patient with CuraAX ...
The primary endpoint is change in standing systolic blood pressure; secondary endpoints include the patient-reported outcome, known as the ...
CuraSen begins Phase IIa trial for neurogenic orthostatic ...
The primary goal of the trial is change in standing systolic blood pressure, with secondary endpoints including the Orthostatic Hypotension ...
CuraSen Therapeutics Presents Positive Phase 1 Safety ...
Data support ongoing Phase 2a study with CuraAX in patients with neurogenic orthostatic hypotension (nOH) to prevent severe decreases in ...
CuraSen Therapeutics Doses First Patient with CuraAX ...
The primary endpoint is change in standing systolic blood pressure; secondary endpoints include the patient-reported outcome, known as the ...
5.
trial.medpath.com
trial.medpath.com/news/d9f61218e7a4bc44/curasen-therapeutics-initiates-phase-iia-trial-for-neurogenic-orthostatic-hypotension-treatmentCuraSen Therapeutics Initiates Phase IIa Trial for Neurogenic ...
CuraSen Therapeutics has dosed the first patient with CuraAX (CST-3056) in a Phase IIa proof-of-concept trial for neurogenic orthostatic ...
News
CuraSen Therapeutics Presents Positive Phase 1 Safety, Pharmacokinetics and Pharmacodynamics Data with CuraAX (CST-3056) at the 2025 American ...
7.
finance.yahoo.com
finance.yahoo.com/news/curasen-therapeutics-presents-positive-phase-140000317.htmlCuraSen Therapeutics Presents Positive Phase 1 Safety ...
CuraSen Therapeutics Presents Positive Phase 1 Safety, Pharmacokinetics and Pharmacodynamics Data with CuraAX (CST-3056) at the 2025 American ...
CuraSen Therapeutics Doses First Patient with CuraAX ...
The Phase 2a, proof-of-concept, dose-ranging study will evaluate safety, tolerability, and impact of CuraAX treatment on orthostatic signs and ...
A Study in Subjects With Neurogenic Orthostatic Hypotension
This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).
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