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Neonatal White Matter Injury Trial (WRAP)

NCT07688746 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Clemastine fumarate

Clemastine fumarate oral suspension

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

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

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
3 Weeks
Max Age
20 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-26
Primary Completion
2028-04-01
Completion
2031-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07688746 on ClinicalTrials.gov