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Could a bladder drug calm POTS? new trial aims to find out

NCT ID NCT07585513

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether mirabegron, a drug currently used for overactive bladder, can reduce symptoms of Postural Orthostatic Tachycardia Syndrome (POTS). Thirty-six adults with confirmed POTS will receive either mirabegron or a placebo. The main goal is to see if the drug lowers the number of symptom episodes patients report each day.

What this could mean

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

Active substance
Mirabegron
What this could lead to
If it works, this could point toward a new treatment option to reduce daily symptoms for people with POTS.
What could go wrong
This is a small, early-phase trial with only 36 participants. The drug may not prove more effective than placebo, 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 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 years and older

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: 1. Provision of a signed and dated informed consent form. 2. Male or female, age ≥ 18 years old. 3. Confirmed POTS diagnosis, which includes chronic (\>3 months) orthostatic intolerance, an increase in heart rate (HR) of ≥30 beats per minute (bpm) without orthostatic hypotension (\>20 mmHg drop of systolic BP) during orthostatic tests. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis. 2. Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illnesses requiring hospitalization) 3. Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)18 4. Active thyrotoxicosis 5. Any experimental medication concomitantly or within 4 weeks of participation in the study 6. Currently participating in a different clinical trial 7. Severe renal impairment (CrCl \< 30 ml/min) 8. Hepatic disease (Child-Pugh Class C) 9. Prisoners 10. Pregnant 11. Breastfeeding 12. Cannot speak, write, or answer questions in English (Validated symptom questionnaires used in this study are available only in English.) 13. Does not have the capacity to consent 14. Patients who are known to be allergic to mirabegron or skin patch electrodes 15. Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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