An Open-label, Dose-escalation, Phase I/Ib Clinical Trial to Assess the Safety and Pharmacokinetics of Clemastine in Preterm Neonates With White Matter Injury (WRAP)
Bridget LaMonica Ostrem, M.D., Ph.D.
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.
Description
Preterm white matter injury (WMI) is the most common type of brain injury in premature infants and is associated with adverse neurological outcomes, including motor and cognitive disability and seizures. Preterm WMI involves an arrest of differentiation in the oligodendroglial cell lineage and a failure of normal developmental myelination. No therapies exist that directly promote brain repair and myelination or can be given at the time that preterm WMI has been identified and is likely most amenable to treatment. The lack of available treatments inherently limits the possibility for functional…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Born at ≤32 weeks gestational age based on prenatal ultrasound or last menstrual period (LMP). 2. Current age of between 35-41 weeks PMA. 3. Imaging evidence of white matter injury on any scan as defined by either brain MRI or cUS criteria: * 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. Exclusion Criteria: 1. Known or suspected metabolic or chromosomal disorde…
Interventions
- DrugClemastine fumarate
Clemastine fumarate oral suspension
Location
- University of California, San FranciscoSan Francisco, California