drugset / Trial / NCT02558972
Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2015-09
- Primary completion
- 2022-12
- Completion
- 2022-12
Publications
- Background Sletten DM, Suarez GA, Low PA, Mandrekar J, Singer W. COMPASS 31: a refined and abbreviated Composite Autonomic Symptom Score. Mayo Clin Proc. 2012 Dec;87(12):1196-201. doi: 10.1016/j.mayocp.2012.10.013.
- Background http: and www.rand.org/health/surveys_tools/mos/mos_core_36item.html. 36-Item Short Form Survey from the RAND Medical Outcomes Study. 2014.
- Background Hays RD, Shapiro MF. An overview of generic health-related quality of life measures for HIV research. Qual Life Res. 1992 Apr;1(2):91-7. doi: 10.1007/BF00439716.
- Background Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Droxidopa | Small molecule | 600 mg | Oral |