Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Neurogenic Orthostatic Hypotension
  Postural Orthostatic Tachycardia Syndrome
• Age: Between 18 Year(s) - 80 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  Healthy Participants

  1. Is 18 (or age of adult) to 80 years of age at the screening visit
  2. Is in good health

  Participants with POTS

  1. Is 18 (or age of adult) to 55 years of age at time of screening
  2. Diagnosis of POTS with ongoing chronic symptoms (=6 months) consistent with POTS that are worse with standing and are relieved by lying down

  Participants with nOH

  1. Is 18 (or age of adult) to 80 years of age at time of screening
  2. Diagnosis of nOH with the following:
     • Presence of neurodegenerative disease (Parkinson’s disease [PD], multiple system atrophy [MSA], Lewy body dementia [LBD], or pure autonomic failure [PAF])
     • Prior documentation of hemodynamic abnormality
     • Ongoing chronic symptoms (=6 months) consistent with nOH that are worse with standing and are relieved by lying down

  All participants

  1. Able to perform all planned study procedures safely and successfully in the opinion of the investigator
  2. Willing and able to comply with clinic visits and study-related procedures
  3. Provide informed consent signed by study participant
  4. Able to understand and complete study-related questionnaires

  
  

You may not be eligible for this study if the following are true:

• Healthy Participants

  1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation

  Participants with POTS and participants with nOH

  1. History of heart failure, cirrhosis, chronic kidney disease, or diabetes mellitus as detected on review during screening of history, physical exam data, laboratory studies, or ECG collected in 12 months prior to enrollment
  2. Any mental disorder that, in the opinion of the investigator, interferes with diagnosis and/or conduct of study
  3. Clinically significant abnormalities on clinical examination performed within 12 months of enrollment that may interfere with study conduct (eg, amputations, wounds, etc)
  4. Inability to forgo use of prohibited concomitant medication prescribed for treatment of orthostatic intolerance as described in the protocol

  All Participants

  1. Members of the clinical site study team and/or is an immediate family member of the clinical site study staff
  2. History of more than moderate alcohol consumption (>2 drinks/day), history of known or suspected drug or substance abuse within a year prior to the screening visit based on the investigator’s discretion
  3. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
  4. Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
  5. Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ, that has been resected with no evidence of metastatic disease for 3 years prior to the screening visit
  6. Participated in any clinical research study evaluating an investigational drug within 90 days or at least 5 half-lives (whichever is longer) of an investigational biologic drug, or at least 4 weeks for other investigational drug, prior to screening
  7. History of allergy or intolerance to skin adhesives
  8. Pregnant or breastfeeding women at screening or study day 1
  • Pregnancy testing is required for women of childbearing potential
  • Pregnancy testing is not required for women who are postmenopausal or permanently sterile.
  • WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
  • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Pregnancy testing is not required for women with documented hysterectomy.