Neonatal White Matter Injury Trial (WRAP)

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.

NCT Number	NCT07688746
Lead Sponsor	Bridget LaMonica Ostrem, M.D., Ph.D. Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions	White Matter Injury, Brain Injury, Fetus and Neonate, Neonatal Brain Injury, Periventricular Leukomalacia, Periventricular White Matter Abnormalities
Enrollment	24 participants
Start Date	2026-07-26
Primary Completion	2028-04-01 (estimated)
Study Completion	2031-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-28