Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Postural Tachycardia Syndrome (POTS), Vasovagal Syncope (VVS), Fainting

In brief

Vasovagal syncope (VVS, simple faint) is the most common cause of transient loss of consciousness and represents the acute episodic form of orthostatic intolerance (OI). Postural tachycardia syndrome (POTS) is the common chronic form of OI. Both are defined by debilitating symptoms and signs while upright relieved by recumbency. Northera should therefore improve both sympathetic splanchnic arterial vasoconstriction and sympathetic splanchnic venoconstriction in POTS and VVS, and may represent an ideal drug to improve the orthostatic response in POTS and VVS.

Key facts

Study ID

NCT02558972

Run by

New York Medical College

People needed

30

Starts

2015-09-01

Expected to finish

2022-12-01

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Both male and female participants are being studied
• Ages 18-30 years old
• POTS cases will be referred for day-to-day Orthostatic Intolerance (OI) with ≥3 symptoms for >6 months.
• POTS will be confirmed by medical history indicating chronic OI, and by a prior 700 tilt table test or standing test showing excessive tachycardia and symptoms OI in the absence of hypotension.
• VVS (fainting) subjects will have at least 2 episodes of postural VVS during the past calendar year.
• Healthy volunteers will be included for Study #1

You may not qualify if…

• Only those free from all systemic illnesses will be eligible to participate. This excludes patients with illnesses associated with autonomic dysfunction such as diabetes, renal disease, congestive heart failure, systemic hypertension, acute and chronic inflammatory diseases, neoplasm, immune mediated disease, trauma, obesity, cancer, supine or upright hypertension, and peripheral vascular disease.
• No subjects will be taking neurally active, or vasoactive drugs. Prior medication will be stopped for at least 2 weeks.

Where it is running

• New York Medical College/Bradhurst building — Hawthorne, New York, United States

Full record on ClinicalTrials.gov

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