A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Assess Safety and Efficacy of Sovateltide in Neonates with Hypoxic-Ischemic Encephalopathy

What this Trial Is About

Hypoxic-ischemic encephalopathy (HIE) is a serious brain condition in newborns caused by lack of oxygen and blood flow around the time of birth. This condition can lead to severe brain injury and long-term disabilities. Researchers are studying the use of sovateltide, a drug that targets brain cell receptors to support nerve cell growth and repair, as a new treatment option for neonates with HIE. Current treatments like therapeutic hypothermia have limited success and must be started quickly after birth, highlighting the need for additional therapies. In this phase II clinical trial, newborns with HIE will receive either sovateltide plus standard care or a placebo (normal saline) plus standard care. The sovateltide or placebo will be given intravenously in a bolus dose every 3 hours on days 1, 3, and 6 after randomization. Both groups will also receive the best available supportive treatments for perinatal asphyxia. Participants will be monitored over 24 months for outcomes such as death or moderate to severe disability, brain injury, seizures, cerebral palsy, blindness or hearing loss, and overall developmental progress using standardized assessments. Safety and tolerance of the treatment will be evaluated, with follow-up visits including clinical evaluations and neurological assessments. The study aims to determine if sovateltide can improve neurological outcomes and survival in newborns affected by HIE.

Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy