Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)
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ClinicalTrials.gov Identifier: NCT02558972 |
Recruitment Status :
Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : April 6, 2022
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Condition or disease | Intervention/treatment | Phase |
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Postural Tachycardia Syndrome (POTS) Vasovagal Syncope (VVS) Fainting | Drug: Northera (Droxidopa) Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Northera Improves Postural Tachycardia Syndrome (POTS) and Postural |
Study Start Date : | September 2015 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
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Placebo Comparator: Northera-single dose
Study #1 -Does single large dose (600mg) of Northera improve upright hemodynamics and orthostatic intolerance in POTS and VVS
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Drug: Northera (Droxidopa)
Study #1 -Supine monitoring is performed for 30 minutes before administration of a single 600mg oral dose of Northera or placebo assigned randomly, After 2 hours supine a 70 degree upright tilt will performed for 10 minutes. On another day, subjects previously given Northera will receive placebo and vice versa and studies repeated. Drug: Placebo Study #1 -Supine monitoring is performed for 30 minutes before administration of a single 600mg oral dose of Northera or placebo assigned randomly, After 2 hours supine a 70 degree upright tilt will performed for 10 minutes. On another day, subjects previously given Northera will receive placebo and vice versa and studies repeated. |
Placebo Comparator: Northera- chronic administration
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.
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Drug: Northera (Droxidopa)
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. Doses will be reduced to the preceding dose if systolic BP>140mmHg or diastolic BP>80mmHg measured in the seated position at home using an automated ambulatory blood pressure cuff 2 hours after receiving an oral dose. Doses will also be reduced if supine BP measured with the head of the bed elevated upon awakening in the morning exceeds 150/90 mmHg. Following a 1 week wash out period, subjects will receive the alternative treatment for 2 additional weeks and instrumented laboratory studies repeated. Drug: Placebo 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. Doses will be reduced to the preceding dose if systolic BP>140mmHg or diastolic BP>80mmHg measured in the seated position at home using an automated ambulatory blood pressure cuff 2 hours after receiving an oral dose. Doses will also be reduced if supine BP measured with the head of the bed elevated upon awakening in the morning exceeds 150/90 mmHg. Following a 1 week wash out period, subjects will receive the alternative treatment for 2 additional weeks and instrumented laboratory studies repeated. |
- Study #1 and Study #2 - Splanchnic and lower extremity pooling (physiological parameter) [ Time Frame: 2 weeks ]Splanchnic and lower extremity pooling will be measured before, during, and after upright tilt. The investigators will use both venous occlusion plethysmography and impedance plethysmography. Venous occlusion plethysmography are made in ml/min by rapidly inflating cuffs to a pressure of 45mmHg and then computing the slope of the time dependent increase in cross limb section. During impedance plethysmography, a Tetrapolar High Resolution Impedance monitor 4-channel digital IPG is used to detect changes in regional blood volume and blood flow in ml/min
- Study #2 -Quality of Life measured by self reporting questionnaire (RAND-36) [ Time Frame: 6 weeks ]The investigators will test whether chronic administration of Northera (Droxidopa) in escalating dose improves quality of life. Quality of life will be measured by the RAND-36 questionnaire. The RAND-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. (2-4)
- Study #2 -Quality of Life measured by self reporting questionnaire (COMPASS 31) [ Time Frame: 6 weeks ]The investigators will test whether chronic administration of Northera (Droxidopa) in escalating dose improves quality of life. Quality of life will be measured by the RAND-36 questionnaire (as shown in the above primary outcome) as well as the COMPASS 31 questionnaire. The COMPASS 31 "was developed as a self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. It was designed to provide a global autonomic severity score and domain scores that are both clinically and scientifically meaningful." "COMPASS 31 is based on the well-established ASP [Autonomic Symptom Profile], a comprehensive questionnaire assessing autonomic symptoms across multiple domains." (1)
- Study #1 and Study #2 -Blood pressure (BP) [ Time Frame: 2 weeks ]During laboratory testing, blood pressure will be continuously monitored in mmHg
- Study #1 and Study #2 -Heart rate (HR) [ Time Frame: 2 weeks ]During laboratory testing, heart rate will be continuously monitored in beats/minute.

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558972
United States, New York | |
New York Medical College/Bradhurst building | |
Hawthorne, New York, United States, 10532 |
Principal Investigator: | Julian M Stewart, M.D., Ph.D. | New York Medical College |
Publications:
Responsible Party: | Julian Stewart, Professor of Pediatrics and Physiology, New York Medical College |
ClinicalTrials.gov Identifier: | NCT02558972 |
Other Study ID Numbers: |
L-11,388 |
First Posted: | September 24, 2015 Key Record Dates |
Last Update Posted: | April 6, 2022 |
Last Verified: | April 2022 |
Postural Tachycardia Syndrome (POTS) Vasovagal Syncope (VVS) Fainting |
Orthostatic Intolerance Droxidopa Northera |
Syncope Postural Orthostatic Tachycardia Syndrome Syncope, Vasovagal Tachycardia Syndrome Disease Pathologic Processes Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Cardiac Conduction System Disease |
Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Droxidopa Antiparkinson Agents Anti-Dyskinesia Agents |