A Phase 1 interventional study of Clemastine fumarate in White Matter Injury, Brain Injury, Fetus and Neonate and Neonatal Brain Injury, sponsored by Bridget LaMonica Ostrem, M.D., Ph.D.. Recruiting at 1 site in United States. Open to participants aged 3 Weeks to 20 Weeks. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Bridget LaMonica Ostrem, M.D., Ph.D. · Phase 1, Interventional, and Treatment
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.
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 recovery in affected infants. Clemastine is an antihistamine and antimuscarinic agent that was identified in a high-throughput screen of FDA-approved compounds that significantly promote myelination in vitro. Clemastine was subsequently shown to promote myelination and improve functional recovery in multiple animal models of WMI, including preterm WMI, and induces remyelination in adult patients with multiple sclerosis. Clemastine is therefore an ideal potential candidate treatment for preterm WMI. The investigators will be conducting a Phase I/Ib open label dose-escalation and dose expansion study to test the safety and pharmacokinetics of oral clemastine treatment in neonates with preterm WMI.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 24 is below the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →This is the only study on the registry with Bridget LaMonica Ostrem, M.D., Ph.D. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Imaging evidence of white matter injury on any scan as defined by either brain MRI or cUS criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose level 1 (0.01 mg/kg/day)
Drug: Clemastine fumarate
Dose level 2 (0.03 mg/kg/day)
Drug: Clemastine fumarate
Dose level 3 (0.05 mg/kg/day)
Drug: Clemastine fumarate
Drug: Clemastine fumarate
Clemastine fumarate oral suspension
Number of subjects who experience dose limiting toxicity
The primary objective is to assess the safety of oral clemastine in preterm neonates with white matter injury (WMI) who have reached at least 35 weeks postmenstrual age (PMA), as measured by the number of subjects who experience dose limiting toxicity (DLT). PMA equals the gestational age (GA) at birth plus chronological age.
Time frame: From study drug administration through 30 days after the last dose
Number of patients who experience any adverse events related to the study drug
Time frame: From study drug administration through 30 days after the last dose
Pharmacokinetics of Clemastine in Preterm Neonates
Oral clearance (CL/F)
Time frame: From day 1 through day 15
Pharmacokinetics of Clemastine in Preterm Neonates
Area under the plasma concentration-time curve from over a 24 hour period (AUC24)
Time frame: From day 1 through day 15
Pharmacokinetics of Clemastine in Preterm Neonates
Average concentration (Cavg)
Time frame: From day 1 through day 15
Pharmacokinetics of Clemastine in Preterm Neonates
Observed concentration at 24 hours post-dose (C24h)
Time frame: From day 1 through day 15
Pharmacokinetics of Clemastine in Preterm Neonates
Maximum observed plasma concentration (Cmax)
Time frame: From day 1 through day 15
Pharmacokinetics of Clemastine in Preterm Neonates
Time of the maximum observed concentration in plasma (Tmax)
Time frame: From day 1 through day 15
Auditory brainstem response (ABR) at 0-6 months corrected age (CA)
Time frame: 0-6 months corrected age
Brain magnetic resonance imaging (MRI) at 2-3 months corrected age (CA)
Time frame: 2-3 months corrected age (CA)
General Movements Assessment (GMA) at 3-5 months corrected age (CA)
Motor Optimality Score: Minimum score is 5, Maximum score is 28; higher scores mean a better outcome. Categorical Classification: Qualitative outcome categorized as normal fidgety, abnormal fidgety, or absent fidgety; normal fidgety movements represent a better outcome.
Time frame: 3-5 months corrected age (CA)
Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) assessment at 18 months corrected age (CA)
Total score: : Minimum 50, Maximum 200; higher scores mean a better outcome.
Time frame: 18 months corrected age (CA)
Bayley Scales of Infant and Toddler Development, 4th Edition (BSID-4) at 22-26 months corrected age (CA)
Standard score: Minimum 45, Maximum 155; higher scores mean a better outcome. Scaled score: Minimum 1, Maximum 19; higher scores mean a better outcome.
Time frame: 22-26 months corrected age (CA)
Gross Motor Function Classification System (GMFCS) score at 22-26 months corrected age (CA)
Scores range from Level I to Level V, where lower levels indicate a better outcome and higher levels indicate a worse outcome
Time frame: 22-26 months corrected age (CA)
Proportion of subjects with any evidence of neurodevelopmental impairment, defined by cerebral palsy (CP) diagnosis, GMFCS≥2 and/or BSID-4 score less than 85 on any scale and/or diagnosis of epilepsy and/or WIDEA-FS >2 SD below normal value for age.
Time frame: 16.9-18 months CA, 22-26 months CA
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Apr 2028, 20 months after the start.
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Studies of the drug tested here: Clemastine