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Neonatal White Matter Injury Trial (WRAP)

Study acronym: WRAP
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Mar 1, 2028 → Apr 1, 2028
See other at-risk trials from Bridget LaMonica Ostrem, M.D., Ph.D.

Record History

  1. Recruitment opened
    • Primary completion pushed from Mar 1, 2028 to Apr 1, 2028
    • Start date changed from estimate of Jul 1, 2026 to Jul 26, 2026
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07688746
Lead Sponsor Bridget LaMonica Ostrem, M.D., Ph.D.
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 White Matter Injury, Brain Injury, Fetus and Neonate, Neonatal Brain Injury, Periventricular Leukomalacia, Periventricular White Matter Abnormalities
Related terms Brain Injuries, Leukomalacia, Periventricular, Premature Birth
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov