Status:
RECRUITING
Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Postural Orthostatic Tachycardia Syndrome (POTS)
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on participants with POTS. The aim of the study is to see how safe, tolerable, and effective...
Eligibility Criteria
Inclusion
- Key
- Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening:
- Increase in HR ≥30 beats per minute (BPM) within 10 minutes of changing from supine to a standing position, as described in the protocol
- Absence of orthostatic hypotension, defined as a decrease in systolic blood pressure (SBP) \>20 mm Hg within 3 minutes of standing
- Absence of other conditions explaining orthostatic tachycardia in the judgment of the investigator, as defined in the protocol
- Ongoing episodic symptoms consistent with POTS (for example, lightheadedness, palpitations, tremulousness, generalized weakness, blurred vision, and fatigue) that are worse with standing and are relieved by lying down and which have been present for ≥3 months
- During screening, a participant must score ≥3 on the Patient Global Impressions of Severity (PGIS)
- Has a body mass index between 18 and 35 kg/m2, inclusive
- Key
Exclusion
- History of hypertension or a seated SBP during screening that is \>140 mm Hg
- SBP during active stand (AS) test during screening, either supine or standing, that is \>140 mm Hg systolic on ≥2 measurements
- Increase in HR \<20 BPM within 10 minutes of changing from supine to a standing position, as defined in protocol
- Is judged by the investigator to have significant heart failure, cardiovascular disease, liver disease, or renal disease (ie, estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2) based on medical history, physical exam, laboratory studies, and/or electrocardiogram (ECG) performed during screening period
- Is confined to bed more than 50% of waking hours
- Within 5 days of screening visit has used medications with direct effects on blood volume, BP, or HR (eg, midodrine, droxidopa, octreotide, clonidine, methyldopa, ivabradine, beta-blockers, calcium channel blockers, pyridostigmine, fludrocortisone, desmopressin, stimulants or intravenous (IV) saline)
- NOTE: Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
November 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 21 2026
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06593600
Start Date
November 13 2024
End Date
April 21 2026
Last Update
September 18 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
2
North County Neurology Associates
Carlsbad, California, United States, 92011
3
Stanford University
Palo Alto, California, United States, 94304
4
Southern California Heart Specialists
Pasadena, California, United States, 91105