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Could a cystic fibrosis drug help stroke patients?

NCT ID NCT05203224

Disease control Sponsor: University of Melbourne 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether adding dornase alfa (a drug used for cystic fibrosis) to standard clot-busting treatment could improve blood flow before a clot removal procedure in people having a major stroke. 330 adults with acute ischemic stroke and a large vessel blockage were enrolled. The goal was to see if the drug helps dissolve clots faster and safely, to guide a future larger trial.

What this could mean

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

Active substance
Dornase alfa (also called DNase or Pulmozyme)
What this could lead to
If successful, this could lead to a new add-on treatment that helps restore blood flow faster in people having a major stroke, potentially reducing brain damage.
What could go wrong
This is an early Phase 2 trial with no control group, so results are preliminary. The drug may not improve outcomes or could increase bleeding risk.

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

330 people

The number who actually took part.

Started

Feb 2022

Finished

Feb 2026

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. Patients presenting with acute ischemic stroke eligible, using standard criteria, to receive IV thrombolytics within 4.5 hours of stroke onset 2. Patient's age is ≥18 years 3. Intention to perform endovascular thrombectomy Imaging inclusion criteria 4. Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery Exclusion Criteria: 1. Intracranial hemorrhage (ICH) identified by CT or MRI 2. Rapidly improving symptoms at the discretion of the investigator 3. Pre-stroke mRS score of ≥ 4 (indicating previous disability) 4. Hypodensity in \>1/3 MCA territory or equivalent proportion of basilar artery territory on non-contrast CT 5. Contraindication to imaging with contrast agents 6. Any terminal illness such that patient would not be expected to survive more than 1 year 7. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. 8. Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

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

Ischemic stroke

Contacts and locations

Locations

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050, Australia

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