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Can two common drugs tame the debilitating symptoms of POTS?

NCT ID NCT07757555

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This trial investigates whether guanfacine or cromolyn sodium—two drugs already approved for other conditions—can improve physical functioning and reduce symptoms like fatigue, brain fog, and gastrointestinal issues in adults with postural orthostatic tachycardia syndrome (POTS). Participants will receive each drug and a placebo in random order over three 4-week periods, while continuing standard lifestyle management. The study aims to see if either drug offers meaningful relief compared to placebo and to explore how they might work.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
guanfacine and cromolyn sodium
What this could lead to
If either drug works, it could offer a new treatment option to improve daily functioning and reduce symptoms like fatigue and brain fog in people with POTS.
What could go wrong
This is an early-phase trial with only 25 participants, so results may not apply broadly. Both drugs are FDA-approved for other conditions but not for POTS, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented diagnosis of POTS per current consensus guidelines: * a heart rate increase of ≥30 bpm within the first 10 minutes of standing or tilt-table testing, without orthostatic hypotension (systolic BP drop ≥20 mmHg) * Frequent symptoms of orthostatic intolerance (e.g., dizziness, palpitations, GI complaints) persisting ≥3 months * Symptom onset within 3 months of a recognized POTS trigger (e.g., infection, vaccination, injury, surgery, pregnancy, or puberty) * Symptomatic response to mediator-targeting medications (e.g., antihistamines, mast cell stabilizers) - also eligible * Presence of flushing, pruritis, urticaria, or angioedema - also eligible * Alternative diagnoses must be excluded via prior clinical workup and laboratory assessment Exclusion Criteria: * Alternative medical causes for symptoms, including: * Anemia, * Active infection, * Dehydration, * Hyperthyroidism, * Pheochromocytoma, * Adrenal insufficiency, * Paraneoplastic conditions * Active neurologic disease (including stroke and epilepsy) * Prolonged immobilization * Current use of medications that cannot be safely discontinued during study enrollment (safety-based exclusion) * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

autonomic nervous system disorder Cognitive Dysfunction dysautonomia Fatigue Mental Fatigue Orthostatic Intolerance postural orthostatic tachycardia syndrome primary dysautonomia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autonomic nervous system diseases Dysautonomia Orthostatic intolerance Postural orthostatic tachycardia syndrome (POTS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.