A Phase 2 interventional study of Dornase Alfa and Isotonic Saline Solution in Ischemic Stroke and Inflammatory Response, sponsored by Ludwig-Maximilians - University of Munich. Recruiting at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Ludwig-Maximilians - University of Munich · Phase 2, Interventional, and Treatment
The goal of this (multicentric, randomised, placebo-controlled single-blinded; phase 2) clinical trial is to test the hypothesis that DNase 1 administration leads to a reduction in systemic immune response measured in patients after acute ischaemic stroke compared to control treatment.
Participants will receive intravenous DNase 1 (500 µg/kg) or placebo (NaCl 0.9%) twice within 24±6 hours after symptom onset (last seen well). Blood samples will be taken at baseline, day 1 and 3. Personal visits will occur on baseline, day 1, 3 and discharge date. A telephone interview will be conducted on day 30±3.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 36 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dornase alfa; intravenous administration; 500 µg/kg
Drug: Dornase Alfa
NaCl 0,9 %; intravenous administration; 0,5 ml/kg
Drug: Isotonic Saline Solution
Patients will receive an intravenous dose of Dornase alfa twice within within 24±6 hours after symptom onset, administered as a bolus.
Also known as: Pulmozyme
Patients will receive an intravenous dose of Isotonic saline solution twice within within 24±6 hours after symptom onset, administered as a bolus.
Also known as: NaCl 0,9%
Concentration of interleukin-1 beta in blood of patients with acute ischemic stroke receiving Dornase alfa compared to placebo treatment with Isotonic Saline Solution.
Outcome of reduced systemic immune response measured by interleukin-1 beta concentration \[pg/ml\] (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: 24±6 hours after symptom onset
cfDNA concentration in blood.
Measurement of cell-free DNA (cfDNA) concentration \[ng/ml\] in blood at day 1 (24±6 hours after symptom onset) compared to the placebo group with experimental analysis.
Time frame: 24±6 hours after symptom onset
DNase 1 activity in blood.
Comparison of DNase 1 activity \[µU/ml\] in blood of both treatment arms measured by Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: 24±6h after symptom onset
Concentration of DNase 1 in blood.
Analysis of the DNase 1 concentration \[ng/ml\] in patient blood treated with Dornase alfa compared to the placebo group by Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: 24±6h after symptom onset
Analysis of the composition of the leukocyte population in blood.
Analysing the leukocyte population \[%\] in blood using flow cytometry in both treatment arms.
Time frame: 24±6 hours after symptom onset
Interleukin-6 concentration in blood after treatment.
Measurement of the interleukin-6 concentration \[pg/ml\] in blood samples (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: 24±6 hours after symptom onset
Caspase 1 concentration in blood after treatment.
Analysing the caspase 1 concentration \[pg/ml\] in blood (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: 24±6 hours after symptom onset
Assessment of patient safety after Dornase alfa treatment.
Safety aspects of intravenous investigational drug administration in acute ischemic stroke patients will be assessed by monitoring all study patients for 30±3 days and analysis of their: * routine clinical diagnostics (worsening stroke is defined as a) progression, hemorrhagic transformation of the index stroke documented by radiological imaging; b) life-threatening need for intervention; c) death from the index stroke; and/or d) increasing disability (as measured by an increase of ≥ 4 points from the lowest NIHSS score measured during hospitalization, or a 1-point increase in mRS), * laboratory parameters (hemoglobin, platelets, neutrophil granulocytes, leukocytes, CRP, GFR, creatinine, IL-6) and * number of adverse events assessed by CTCAE current version.
Time frame: 30±3 days after symptom onset
Comparison of the incidence of infections and antibiotic treatment in both treatment arms.
Comparing the incidence of infections and antibiotic treatment after Dornase alfa and Isotonic Saline Solution treatment over a period of 30±3 days after symptom onset.
Time frame: 30±3 days after symptom onset
Functional neurological outcome scores (National Institute of Health Stroke Scale [NIHSS, 0-42] and Modified Rankin Scale [mRS, 0-6]) at both treatment arms.
Analysing changes of neurological scores (National Institute of Health Stroke Scale \[NIHSS, 0-42\] and Modified Rankin Scale \[mRS, 0-6\]) from baseline to last visit 30±3 days after symptom onset.
Time frame: 30±3 days after symptom onset
Plan to share: No
Start is estimated for Oct 2026; primary completion for Mar 2028, 17 months later.
Of 83 non-industry phase 2 interventional studies under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's planned 17 months is below that.
Counting every sponsor, half of 124 studies reached it within 28 months; a quarter within 15 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Dornase alfa
Ludwig-Maximilians - University of Munich →