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Neonatal White Matter Injury Trial (WRAP)
Sponsor: Bridget LaMonica Ostrem, M.D., Ph.D.
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.
Official title: 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)
Key Details
Gender
All
Age Range
3 Weeks - 20 Weeks
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-07-01
Completion Date
2031-07-01
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Clemastine fumarate
Clemastine fumarate oral suspension
Locations (1)
University of California, San Francisco
San Francisco, California, United States