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WRAP Trial: Clemastine for Neonatal White Matter Injury

This study, called WRAP, is looking at a drug called clemastine fumarate for babies born prematurely who have white matter injury (a type of brain injury). Clemastine fumarate is not yet approved for this use. The main goal is to see if clemastine fumarate is safe for these infants. Researchers also want to understand how much of the drug gets into a baby's body and how long it stays there. You might be able to join if your baby was born at 32 weeks or less, is currently between 35-41 weeks post-menstrual age (PMA), and has imaging evidence of white matter injury. The study is currently unclear on its recruitment status and plans to enroll 24 babies. The primary measure of success for this study is to track any serious side effects from the drug for up to 30 days after the last dose.

Study design
This is an interventional study with a planned enrollment of 24 participants. It is an open-label study, meaning both you and the study team will know which treatment your baby is receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track any serious side effects from the study drug through 30 days after the last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07688746

Neonatal White Matter Injury Trial (WRAP)

Recruiting
PHASE1Ages 3–20InterventionalTreatment
Bridget LaMonica Ostrem, M.D., Ph.D.
~24 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Clemastine fumarate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects who experience dose limiting toxicity
Measured over From study drug administration through 30 days after the last dose

Conditions

White Matter Injury
Brain Injury, Fetus and Neonate
Neonatal Brain Injury
Periventricular Leukomalacia
Periventricular White Matter Abnormalities

Explore related trials

White Matter Injury

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Bridget Ostrem, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Audrey Hernando, BS
[email protected]
415-502-2425
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Brain MRI with Grade Ib WMI or higher based on the Martinez-Biarge et al 2016 criteria.
cUS with Grade 3 or higher white matter abnormalities based on Miller et al 2003 criteria. 4. Currently hospitalized in a participating intensive care nursery.

What this trial measures

  • Number of subjects who experience dose limiting toxicityFrom study drug administration through 30 days after the last dose

    The primary objective is to assess the safety of oral clemastine in preterm neonates with white matter injury (WMI) who have reached at least 35 weeks postmenstrual age (PMA), as measured by the number of subjects who experience dose limiting toxicity (DLT). PMA equals the gestational age (GA) at birth plus chronological age.