drugset / Trial / NCT05880524
Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)
Phase 2
Unknown
36 enrolled
Ludwig-Maximilians - University of Munich
University Hospital Erlangen · collabUniversity Hospital Regensburg · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2024-12
- Primary completion
- 2025-12
- Completion
- 2026-01
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | dornase alfa | Protein / enzyme biologic | 500 ug/kg | Intravenous |