drugset / Trial / NCT07688746
Neonatal White Matter Injury Trial (WRAP)
Phase 1
Not yet recruiting
24 enrolled
Bridget LaMonica Ostrem, M.D., Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS) · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2028-03-01
- Completion
- 2031-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clemastine | Small molecule | 0.01 mg/kg | Oral |
| Subject | Clemastine | Small molecule | 0.03 mg/kg | Oral |
| Subject | Clemastine | Small molecule | 0.05 mg/kg | Oral |