Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia · 2026
Phase III Open-Label, Randomized Clinical Trial of Epidermal Growth Factor and Growth Hormone Releasing Hexapeptide in Acute Ischemic Stroke.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Hernández-Bernal Francisco, Subirós-Martínez Nelvys, Gutiérrez-Ronquillo Juan H, Colina-Ávila Elizabeth, Guevara-Rodríguez Marbelys, Estenoz-García Donner, Catasús-Álvarez Karem, Martín-Bauta Yenima, Pérez-Saad Héctor, Manso-López Ana M, Batista-Izquierdo Alejandro, González-Dalmau Evelio, Amador-Nuñez Taimy, Muzio-González Verena L, Guillén-Nieto Gerardo E, Garcia-Del-Barco-Herrera Diana, COURAGE COmbined therapeUtic appRoAch durinG acute strokE Research Group
Аннотация
UNLABELLED: Stroke remains a critical condition. Combined therapy of Epidermal Growth Factor (EGF) and Growth Hormone Releasing Peptide-6 (GHRP6) has shown potential benefits in stroke patients. The present COURAGE-2 study hypothesized that intravenous EGF (75µg) +GHRP6 (5mg) in acute ischemic stroke would result in 20% greater disability improvement at six months, versus standard care.
METHODS: A multicenter, randomized, open-label, phase-III trial enrolled patients within 12 hours of symptom onset, and NIHSS score of 5-20. Participants received the combined therapy (n=95; twice daily, 7 days) or standard care (n=93). Primary endpoint was safety and efficacy at 3 and 6 months, measured by modified Rankin Scale (mRS). Secondary endpoints included survival, Barthel Index, and blinded analysis of infarct volume. Sensitivity analyses used a NIHSS≥12 threshold.
RESULTS: Patients were 63.5±11.3 years-old, 110 men, baseline NIHSS score of 9.5 (95%CI: 8.9-10) and mean time to treatment of 7.3±2.8 h. Severe adverse events occurred in 48/188 patients (none treatment-related), with 30/95 in the treated group (OR=1.92; 95%CI: 0.981-3.767). In the intention-to-treat population, no differences were found in mRS, Barthel index nor survival. However, severe-stroke patients (NIHSS≥15, n=27) treated with EGF+GHRP6 showed reduced disability (mRS6-months=2.6, 95%CI: 1.3-3.8 vs Control 4.7, 95%CI: 2.6-6; p=0.03), and mortality risk (HR=0.18, 95%CI: 0.03-0.96; p=0.045). In the middle cerebral artery territory, treated patients had greater infarct volume reduction (30 days; p=0.041). Similar outcomes were found using NIHSS≥12 threshold.
CONCLUSIONS: The Courage-2 study missed the primary endpoint but suggested potential benefit in moderate-to-severe stroke, warranting further studies targeting this subpopulation.
METHODS: A multicenter, randomized, open-label, phase-III trial enrolled patients within 12 hours of symptom onset, and NIHSS score of 5-20. Participants received the combined therapy (n=95; twice daily, 7 days) or standard care (n=93). Primary endpoint was safety and efficacy at 3 and 6 months, measured by modified Rankin Scale (mRS). Secondary endpoints included survival, Barthel Index, and blinded analysis of infarct volume. Sensitivity analyses used a NIHSS≥12 threshold.
RESULTS: Patients were 63.5±11.3 years-old, 110 men, baseline NIHSS score of 9.5 (95%CI: 8.9-10) and mean time to treatment of 7.3±2.8 h. Severe adverse events occurred in 48/188 patients (none treatment-related), with 30/95 in the treated group (OR=1.92; 95%CI: 0.981-3.767). In the intention-to-treat population, no differences were found in mRS, Barthel index nor survival. However, severe-stroke patients (NIHSS≥15, n=27) treated with EGF+GHRP6 showed reduced disability (mRS6-months=2.6, 95%CI: 1.3-3.8 vs Control 4.7, 95%CI: 2.6-6; p=0.03), and mortality risk (HR=0.18, 95%CI: 0.03-0.96; p=0.045). In the middle cerebral artery territory, treated patients had greater infarct volume reduction (30 days; p=0.041). Similar outcomes were found using NIHSS≥12 threshold.
CONCLUSIONS: The Courage-2 study missed the primary endpoint but suggested potential benefit in moderate-to-severe stroke, warranting further studies targeting this subpopulation.