Your browser doesn't support javascript.
loading
Intravenous Odatroltide for Acute Ischemic Stroke Within 24 Hours of Onset: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.
Chao, A-Ching; Lee, Tsong-Hai; Pettigrew, Luther C; Hannawi, Yousef; Huang, Hung-Yu; Chi, Nai-Fang; Chan, Lung; Chen, Po-Lin; Devlin, Thomas.
Afiliación
  • Chao AC; Department of Neurology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
  • Lee TH; College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • Pettigrew LC; Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.
  • Hannawi Y; Department of Neurology, University of Kentucky Chandler Medical Center, Lexington, KY, USA.
  • Huang HY; Division of Cerebrovascular Diseases and Neurocritical Care, Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
  • Chi NF; Department of Neurology, China Medical University Hospital, Taichung, Taiwan.
  • Chan L; School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
  • Chen PL; Division of Cerebrovascular Diseases, Neurological Institute, Taipei Veterans General Hospital, Taipei, Taiwan.
  • Devlin T; Department of Neurology, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan.
Drug Des Devel Ther ; 18: 2033-2042, 2024.
Article en En | MEDLINE | ID: mdl-38859883
ABSTRACT

Purpose:

Odatroltide (LT3001), a novel small synthetic peptide molecule designed to recanalize occluded blood vessels and reduce reperfusion injury, is safe and efficacious in multiple embolic stroke animal models. This study aimed to investigate the safety and tolerability of intravenous administration of odatroltide in patients with acute ischemic stroke within 24 hours of onset. Patients and

Methods:

Patients with National Institutes of Health Stroke Scale (NIHSS 4-30) who were untreated with intravenous thrombolysis or endovascular thrombectomy were randomized (21) to receive a single dose of odatroltide (0.025 mg/kg) or placebo within 24 hours of stroke symptom onset. The primary safety outcome was symptomatic intracranial hemorrhage (sICH) occurrence within 36 hours.

Results:

Twenty-four patients were enrolled and randomized; of these 16 and 8 received intravenous odatroltide infusion and placebo, respectively. sICH did not occur in both groups, and other safety measures were comparable between the groups. The rate of excellent functional outcome (modified Rankin Scale score, 0-1, at 90 days) was 21% and 14% in the odatroltide and placebo groups, respectively. Furthermore, 47% and 14% of patients in the odatroltide and placebo groups, respectively, showed major neurological improvement (NIHSS improvement ≥4 points from baseline to 30 days). Among the 9 odatroltide-treated patients with baseline NIHSS ≥6, 78% showed major neurological improvement.

Conclusion:

Compared with placebo, treatment with intravenous odatroltide within 24 hours following onset of ischemic stroke appears to be safe and may be associated with better neurological and functional outcomes. However, the efficacy and safety of odatroltide requires further confirmation in the next phase of clinical trials. Clinical Trial Registration Clinicaltrials.gov identifier NCT04091945.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Accidente Cerebrovascular Isquémico Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Drug Des Devel Ther Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Nueva Zelanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Accidente Cerebrovascular Isquémico Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Drug Des Devel Ther Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Taiwán Pais de publicación: Nueva Zelanda