Can DNase 1 help reduce inflammation after an ischemic stroke?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, placebo-controlled, single-blind phase 2 trial evaluating whether intravenous DNase 1 can dampen systemic inflammation after acute ischemic stroke. Participants receive DNase 1 (500 µg/kg) or saline twice within about 24 hours of last known well, with blood draws on baseline, day 1 and day 3, and follow-up visits through discharge and a telephone check at day 30. The study uses standard stroke assessment and safety monitoring to explore biological response and potential clinical impact. Eligible adults have significant stroke burden (NIHSS ≥10) with imaging ruling out hemorrhage, and must consent to participate. Key exclusions include intracranial hemorrhage, active cancer, immunosuppression, serious infection, and pregnancy or breastfeeding. The trial is led by Ludwig-Maximilians-Universität München with collaborators at nearby centers in Germany.

Why it matters

Who can join: the full rules

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.

Where it's running

• Charité Universitätsmedizin
  Berlin, Germany Recruiting
• University Medical Center Hamburg-Eppendorf
  Hamburg, Germany Recruiting
• MHH Hannover
  Hanover, Germany Recruiting
• Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital
  Munich, Bavaria, Germany Not yet recruiting
• TUM Klinikum München
  Munich, Germany Not yet recruiting

Study contacts

• Principal investigator: Arthur Liesz, Prof. Dr. — Institute for Stroke and Dementia Research, LMU Hospital
• Study coordinator: Arthur Liesz, Prof. Dr.
• Email: arthur.liesz@med.uni-muenchen.de
• Phone: +49 89 4400 46169

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.