Phase 1 Rare Disease Trial, Recruiting NCT02897063 Sponsor: Vanderbilt University Medical Center Condition: Rare Disease
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Phase 1 Rare Disease Trial, Recruiting

NCT02897063
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults between the ages of 40 and 80 (men or women) who have been diagnosed with possible or probable Multiple System Atrophy, Pure Autonomic Failure, or Parkinson's disease, based on recognized medical guidelines.
  • People who experience a significant drop in blood pressure when standing up (a condition called neurogenic orthostatic hypotension), confirmed by specialized testing that shows the nervous system is not properly controlling blood pressure.
  • People who are able and willing to give their informed consent to take part in the study.

Who may not be able to join:

  • People who have high blood pressure while lying down (a reading of 160 mmHg or higher on two separate occasions).
  • People who are pregnant.
  • People who have a condition known to damage the nerves that control body functions, such as diabetes, amyloidosis, certain blood protein disorders, or autoimmune nerve conditions.
  • People who have a known aortic aneurysm, or who have had chest, abdominal, or pelvic surgery in the past 6 months.
  • People who have hernias in the abdomen or groin that are causing symptoms.
  • People who have severe acid reflux (heartburn).
  • People with recent broken or cracked ribs or fractures in the spine.
  • People who have a medical device on or inside the abdomen that could interfere with abdominal compression.
  • People who cannot tolerate any increase in pressure in the abdomen.
  • People with unstable heart disease, or who have had a major heart or neurological event in the past 6 months, or who have other health or mental health concerns that the trial team believes would prevent them from completing the study (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Italo Biaggioni, MD, Vanderbilt University Medical Center

Phone: 615-343-6862

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
1 September 2016
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Stroke volume

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov