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NOT YET RECRUITING
NCT07688746
PHASE1

Neonatal White Matter Injury Trial (WRAP)

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Clemastine fumarate

Clemastine fumarate oral suspension

Locations (1)

University of California, San Francisco

San Francisco, California, United States