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Sympathomimetic

Placebo for Postural Orthostatic Tachycardia Syndrome

Phase 2
Waitlist Available
Led By Julian M Stewart, M.D., Ph.D.
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial is testing a drug to treat vasovagal syncope (VVS) and postural tachycardia syndrome (POTS).

Eligible Conditions
  • Postural Orthostatic Tachycardia Syndrome
  • Vasovagal Syncope
  • Fainting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lower Extremity
Study #2 -Quality of Life measured by self reporting questionnaire (COMPASS 31)
Study #2 -Quality of Life measured by self reporting questionnaire (RAND-36)
Secondary outcome measures
Study #1 and Study #2 -Blood pressure (BP)
Study #1 and Study #2 -Heart rate (HR)

Trial Design

2Treatment groups
Placebo Group
Group I: Northera-single dosePlacebo Group2 Interventions
Study #1 -Does single large dose (600mg) of Northera improve upright hemodynamics and orthostatic intolerance in POTS and VVS
Group II: Northera- chronic administrationPlacebo Group2 Interventions
Study #2 -Patients will randomized to receive Northera or placebo for two weeks after which they will return for instrumented tilt studies as in Study 1. Doses of Northera will be titrated upwards by 100mg/dose every 48 hours from a starting dose of 100mg three times a day to a maximum of 600mg three times a day.

Find a Location

Who is running the clinical trial?

New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,031 Total Patients Enrolled
5 Trials studying Postural Orthostatic Tachycardia Syndrome
290 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Lundbeck LLCIndustry Sponsor
15 Previous Clinical Trials
10,507 Total Patients Enrolled
Julian M Stewart, M.D., Ph.D.Principal InvestigatorNew York Medical College

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Quality of Life ResearchJournal
An Overview of Generic Health-related Quality of Life Measures for HIV Research
Hays, R. D., and M. F. Shapiro. 1992. “An Overview of Generic Health-related Quality of Life Measures for HIV Research”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/bf00439716.
Mayo Clinic ProceedingsJournal
COMPASS 31: A Refined and Abbreviated Composite Autonomic Symptom Score
Sletten, David M., Guillermo A. Suarez, Phillip A. Low, Jay Mandrekar, and Wolfgang Singer. 2012. “COMPASS 31: A Refined and Abbreviated Composite Autonomic Symptom Score”. Mayo Clinic Proceedings. Elsevier BV. doi:10.1016/j.mayocp.2012.10.013.
Acta OrthopaedicaJournal
Patient-reported Outcome Measures in Arthroplasty Registries
Rolfson, Ola, Kate Eresian Chenok, Eric Bohm, Anne Lübbeke, Geke Denissen, Jennifer Dunn, Stephen Lyman, et al.. 2016. “Patient-reported Outcome Measures in Arthroplasty Registries”. Acta Orthopaedica. Medical Journals Sweden AB. doi:10.1080/17453674.2016.1181815.
clinicaltrials.govStudy
Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)
Julian Stewart 2015. "Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02558972.
~3 spots leftby Apr 2025
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