Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)

NCT05880524 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: RESCIND-1-20232022-003410-37
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this (monocentric, 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.

Conditions

Ischemic Stroke; Inflammatory Response

Outcome Measures

Primary Outcomes (1)

• 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).

  24±6 hours after symptom onset

Secondary Outcomes (9)

• cfDNA concentration in blood.

  24±6 hours after symptom onset

• DNase 1 activity in blood.

  24±6h after symptom onset

• Concentration of DNase 1 in blood.

  24±6h after symptom onset

• Analysis of the composition of the leukocyte population in blood.

  24±6 hours after symptom onset

• Interleukin-6 concentration in blood after treatment.

  24±6 hours after symptom onset

Study Arms (2)

Pulmozyme

ACTIVE COMPARATOR

Dornase alfa; intravenous administration; 500 µg/kg

Drug: Dornase Alfa

Isotonic Saline Solution

PLACEBO COMPARATOR

NaCl 0,9 %; intravenous administration; 0,5 ml/kg

Drug: Isotonic Saline Solution

Interventions

Dornase Alfa DRUG

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

Pulmozyme

Isotonic Saline Solution DRUG

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%

Isotonic Saline Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiency requiring dialysis.

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• University Hospital Erlangen: collaborator
• University Hospital Regensburg: collaborator

Study Sites (1)

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

Munich, Bavaria, 81377, Germany

Location

Related Publications (2)

• Sharma N, Dwivedi DJ, Fux L, Hayon Y, Ruderfer I, Nataf Y, Cani E, Liaw PC. Intravenous Delivery of Long-Acting Dnase I (PRX-119) In a Murine Model of Polymicrobial Abdominal Sepsis. Shock. 2026 Jan 1;65(1):76-84. doi: 10.1097/SHK.0000000000002666. Epub 2025 Jul 8.

  PMID: 40705350 DERIVED

• Di G, Vazquez-Reyes S, Diaz B, Pena-Martinez C, Garcia-Culebras A, Cuartero MI, Moraga A, Pradillo JM, Esposito E, Lo EH, Moro MA, Lizasoain I. Daytime DNase-I Administration Protects Mice From Ischemic Stroke Without Inducing Bleeding or tPA-Induced Hemorrhagic Transformation, Even With Aspirin Pretreatment. Stroke. 2025 Feb;56(2):527-532. doi: 10.1161/STROKEAHA.124.049961. Epub 2025 Jan 27.

  PMID: 39869712 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

dornase alfa

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martin Dichgans, Prof. Dr.

  Institute for Stroke and Dementia Research, LMU Hospital

  STUDY DIRECTOR

Central Study Contacts

Arthur Liesz, Prof. Dr.

CONTACT

+49 89 4400 46242; arthur.liesz@med.uni-muenchen.de

Saskia Wernsdorf

CONTACT

+49 89 4400 46119; saskia.wernsdorf@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Delegated Person and Principal Investigator

Model Details: Monocentric, randomised, placebo-controlled single-blinded, Phase 2 trial

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: May 30, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)