Neonatal White Matter Injury Trial (WRAP)

Part of paid clinical trials in San Francisco, California.

Sponsor
Bridget LaMonica Ostrem, M.D., Ph.D.
Study ID
NCT07688746
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
3 Weeks - 20 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Clemastine fumarate — DRUG
    Clemastine fumarate oral suspension

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2028
Completion
Jul 1, 2031

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level 1
    Dose level 1 (0.01 mg/kg/day)
  • Experimental: Dose level 2
    Dose level 2 (0.03 mg/kg/day)
  • Experimental: Dose level 3
    Dose level 3 (0.05 mg/kg/day)
  • Experimental: Dose level 4

Primary Outcome Measure

Number of subjects who experience dose limiting toxicity [ Time Frame: From study drug administration through 30 days after the last dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158
Audrey Hernando
[email protected]
415-502-2425
Bridget Ostrem, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CA

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