RecruitingPhase 1NCT07688746

Neonatal White Matter Injury Trial (WRAP)

An Open-label, Dose-escalation, Phase I/Ib Clinical Trial to Assess the Safety and Pharmacokinetics of Clemastine in Preterm Neonates With White Matter Injury (WRAP)

Sponsor

Bridget LaMonica Ostrem, M.D., Ph.D.

Enrollment

24 participants

Start Date

Jul 26, 2026

Study Type

INTERVENTIONAL

Conditions

Neonatal Brain Injury White Matter Injury Brain Injury, Fetus and Neonate Periventricular White Matter Abnormalities Periventricular leukomalacia.

Summary

The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental. This means that the drug is not approved by the Food and Drug Administration (FDA) for the treatment of white matter injury. The main purpose of this study is to learn whether clemastine is safe to give to infants with white matter injury. The researchers also want to understand how much clemastine gets into an infant's body when the medication is taken by mouth, and how long it stays in the body.

Eligibility

Min Age: 3 WeeksMax Age: 20 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Clemastine fumarate for people with brain injury, fetus and neonate, neonatal brain injury, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 3 Weeks to 20 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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