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Can an enzyme calm the immune storm after a stroke?

NCT ID NCT05880524

Disease control Sponsor: Ludwig-Maximilians - University of Munich Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether an intravenous dose of the enzyme dornase alfa can reduce the body's inflammatory response after an acute ischemic stroke. The trial enrolls 36 adults who arrive at the hospital within 12 hours of symptom onset and have moderate to severe stroke symptoms. Participants receive either dornase alfa or a saline placebo twice within about a day of symptom onset, and researchers measure inflammatory markers in their blood over the following days.

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, an enzyme drug given intravenously
What this could lead to
If it works, this could offer a way to calm the body's inflammatory response after a stroke and limit further brain damage.
What could go wrong
This is a small phase 2 trial with 36 participants, so any signal may not hold in larger studies. DNase can also affect blood clotting and immune defenses, which researchers must watch closely.

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

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 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: * Patients with suspected acute ischemic stroke with symptom onset (last-seen-well) until Investigational drug application of less than 12 hours. * Consent to participate in the study. * Age ≥ 18 years. * NIHSS ≥10 at admission. Exclusion Criteria: * Presence of any of the following conditions: Sinus or cerebral venous thrombosis, intracerebral haemorrhage, subarachnoid haemorrhage on qualified imaging (cCT with CT-A or MRI with MR-A). However, petechial haemorrhagic transformations of the index infarct and cerebral microhaemorrhages may be included. * Active malignant tumour disease in the last 6 months. * Current known immunosuppression due to immunomodulatory medication with immunosuppressive dose or underlying immunosuppressive disease (e.g. HIV). * Acute fulminant infectious disease in the last 7 days (fever \> 38.5°C or suspected by the Investigator). * Breastfeeding or pregnant woman, women of childbearing age without known use of contraceptives with positive urine or serum beta-human choriogonadotropin test. * Ischemic stroke or myocardial infarction in the previous 30 days. * Surgery in the previous 30 days, except minor dermatological or gynaecological surgery without anaesthesia and wound healing disorders and patients with thrombectomy. * Estimated or known weight \> 100 kg. * Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant protein products derived from Chinese hamster ovary cells. * Thrombocytopenia, leukocyte count \<1500/μl. * Known participation in another clinical trial investigating a drug and/or medical product in the last 7 days before study inclusion. * Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiency requiring dialysis.

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Conditions

The condition(s) this trial relates to.

inflammatory disease ischemic stroke

As listed by the trial registrant

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

Inflammatory response Ischemic stroke

How to take part

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

  1. The places running it

    5 sites. 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

  • Charité Universitätsmedizin

    RECRUITING

    Berlin, Germany

  • Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital

    NOT_YET_RECRUITING

    Munich, Bavaria, 81377, Germany

  • MHH Hannover

    RECRUITING

    Hanover, Germany

  • TUM Klinikum München

    NOT_YET_RECRUITING

    Munich, Germany

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

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