Overview

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

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
New York Medical College
Collaborator:
Lundbeck LLC
Treatments:
Droxidopa
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.