[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07089043":3,"trial-entities:NCT07089043":108,"trial-summary:NCT07089043":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":101,"overall_officials":102,"references":106,"see_also_links":107},"NCT07089043","CST3056-CLIN-021","A Study in Subjects With Neurogenic Orthostatic Hypotension","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","ACTIVE_NOT_RECRUITING","2026-10","2026-08","2026-08-28","2025-09-12","CuraSen Therapeutics, Inc.","INDUSTRY",false,"This is a study to evaluate the effects of CST-3056 on orthostatic symptoms and signs in subjects with neurogenic orthostatic hypotension (nOH).","This is a study to evaluate the effects of CST-3056 on orthostatic symptoms in subjects with nOH.\n\nSubjects who use direct or indirect α1-AR agonists for treatment of nOH will need to discontinue those treatments for at least 1 day or 5 half-lives (whichever is longer) prior to assessment of orthostatic measures during Screening, and again prior to initiation of dosing for study drug on Day 1.\n\nFollowing confirmation of eligibility, subjects will be enrolled and participate in a single-blind dose ranging study. Single oral doses of CST-3056 will be administered once-daily for five days (Days 1 through 4 and the Optimal Dose Day \\[Day 5\\]), as tolerated. The Individual Optimal Dose will be determined based on observations for each subject over Day 1 through Day 4, including standing blood pressure, and safety\u002Ftolerability of the dose.\n\nBetween 3-7 days after discharge from the in-patient stay, the Investigator or designee will contact the subject by telephone to review the subject's health status. Any adverse events reported by phone will be recorded and followed as medically appropriate as determined by the Investigator.",[19],"Neurogenic Orthostatic Hypotension",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},12,"ACTUAL",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","CST-3056","Administered as an oral solution",[31],{"type":30,"name":35,"description":32,"armGroupLabels":36},"Placebo",[35],[38],{"measure":39,"description":40,"timeFrame":41},"Change from Baseline in Standing Systolic Blood Pressure","Baseline is defined as the pre-dose measurement on Day 1","Baseline and 1, 2, 3, and 4 hours post-dose on Days 1 to 4",[43,46,50],{"measure":44,"description":40,"timeFrame":45},"Change from Baseline in Seated Systolic Blood Pressure relative to placebo","Baseline and 5 minutes post-dose on Days 1 to 4",{"measure":47,"description":48,"timeFrame":49},"Change from Baseline in the Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 relative to placebo","The question asks subjects to rate the severity of their orthostatic hypotension symptoms (dizziness, lightheaded, feeling faint, or felling like you might black out) on an 11-point scale from 0-10, with 0 indicating no symptoms\u002Fno interference and 10 indicating the worst possible symptoms\u002Fcomplete interference. A higher score indicates a worse outcome. Baseline is defined as the pre-dose measurement on Day 1.","Baseline and 3 hours post-dose on Days 1 to 4",{"measure":51,"description":52,"timeFrame":53},"Change from Baseline in the heads-up tilt table test (HUTT)","Subjects will have blood pressure and heart rate measured continuously and\u002For intermittently after resting in the supine position and pre-dose measurements will be taken twice. After dosing, subjects will undergo a graded HUTT at 30, 45 and 60 degrees. Measurements will be taken continuously and\u002For intermittently and at 1 and 3 minutes after each degree of tilt.","Baseline and 3 hours post-dose on Optimal Dose Day (Day 5)","ALL","18 Years","85 Years",{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Inclusion Criteria:\n\n1. Male or female subjects ≥ 18 and ≤ 85 years of age, at time of informed consent.\n2. Diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease or pure autonomic failure (i.e. neurogenic orthostatic hypotension).\n3. 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.\n4. At Screening, subjects must have a score ≥4 on the Orthostatic Hypotension Symptom Assessment (OHSA) scale question #1.\n5. Currently receiving, or known to be responsive to, direct or indirect α1-AR agonists (e.g., midodrine, droxidopa) for treatment of nOH.\n6. 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.\n7. Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg\u002Fm2, inclusive at Screening.\n8. Stable medical conditions for 3 months prior to Screening.\n9. For patients taking antiparkinsonian medication: stable dose of levodopa, dopamine agonist, amantadine, and\u002For monoamine oxidase B inhibitor, i.e. unchanged for 1 month.\n10. Subject is ambulatory with\u002Fwithout the use of an assistive device.\n11. Willing to follow the protocol requirements and comply with protocol restrictions.\n12. Capable of providing informed consent and complying with study procedures.\n13. Able to speak, understand, and read English.\n\nExclusion Criteria:\n\n1. Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.\n2. 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).\n3. Supine SBP ≥ 170 mm Hg or seated SBP ≥ 140 mm Hg at Screening.\n4. 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).\n5. Concomitant use of anti-hypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.\n6. 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.\n7. 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).\n8. 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.\n9. History of suicidal ideation or an episode of clinically severe depression as determined by the Investigator.\n10. Clinically significant abnormalities of ECG, including QTcF \\> 450 ms, for males and QTcF \\> 470 ms for females, and\u002For HR \\\u003C 50 beats per minute, or evidence of clinically significant bundle branch blocks, as indicated by 12-lead ECG in a supine position at Screening.\n11. A calculated eGFR of ≤60 mL\u002Fmin\u002F1.73m2 according to the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation at Screening.\n12. Current use of any prohibited prescription medication during Screening or throughout study, unless approved by both the Investigator and the Sponsor Medical Monitor.\n13. Prior treatment with any investigational drug ≤90 days prior to dosing (Day 1), or ≤5 half-lives of the drug (whichever is longer), or current enrollment in any other study treatment or disease study, except for observational studies.\n14. Known or suspected alcohol or substance abuse within the past 12 months and\u002For positive test for alcohol or drugs of abuse at Screening.\n15. Positive screening test for human immunodeficiency virus (HIV), hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis B surface antigen \\[HbsAg\\] at Screening).\n16. Females who are breastfeeding.\n17. Any other reason for which the Investigator considers it is not in the best interest of the subject to undertake the study.",[62,63],"ADULT","OLDER_ADULT",[65,74,81,88,94],{"facility":66,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"CuraSen Investigational Site","Scottsdale","Arizona","85251","United States",{"lat":72,"lon":73},33.50921,-111.89903,{"facility":66,"city":75,"state":76,"zip":77,"country":70,"geoPoint":78},"Farmington Hills","Michigan","48334",{"lat":79,"lon":80},42.48531,-83.37716,{"facility":66,"city":82,"state":83,"zip":84,"country":70,"geoPoint":85},"Eatontown","New Jersey","07724",{"lat":86,"lon":87},40.29622,-74.05097,{"facility":66,"city":89,"state":89,"zip":90,"country":70,"geoPoint":91},"New York","10019",{"lat":92,"lon":93},40.71427,-74.00597,{"facility":66,"city":95,"state":96,"zip":97,"country":70,"geoPoint":98},"Nashville","Tennessee","37240",{"lat":99,"lon":100},36.16589,-86.78444,[],[103],{"name":104,"affiliation":13,"role":105},"Chief Medical Officer","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":110},[19],[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is an interventional study, meaning participants will receive a specific treatment. It is a single-blind, dose-ranging study, meaning you won't know if you're getting CST-3056 or a placebo (an inactive substance), but the researchers will.","completed","A Study of CST-3056 for Neurogenic Orthostatic Hypotension","This study is looking at how a drug called CST-3056, given as an oral solution, affects people with neurogenic orthostatic hypotension (nOH). nOH is a condition where your blood pressure drops significantly when you stand up, often due to Parkinson's disease or pure autonomic failure. Researchers want to see if CST-3056 can improve symptoms and signs of nOH. You might be able to join if you are between 18 and 85 years old and have been diagnosed with symptomatic nOH. The main way they will measure success is by checking changes in your standing systolic blood pressure (the top number in a blood pressure reading) over several hours after taking the drug. The study is currently unclear about its recruitment status and plans to enroll 12 participants.","Between 3-7 days after leaving the in-patient stay, you will be contacted by phone to check on your health status.",127,"You would take single oral doses of CST-3056 or placebo once daily for five days. You may need to stop certain medications for at least one day before screening and before starting the study drug.","Not stated in the trial record.",[31],"v2"]