Clemastine for White Matter Injury
(WRAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for white matter injury, a brain injury often seen in premature babies. Researchers are testing clemastine fumarate, an antihistamine, to determine its safety for infants with this condition and to understand how the body processes the drug. The trial includes several groups receiving different doses of clemastine to identify the safest and most effective amount. Babies born at or before 32 weeks and diagnosed with white matter injury might be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that clemastine is likely to be safe for infants with white matter injury?
Research has shown that clemastine has been studied for its effects on brain injuries, such as damage to white matter. In studies with mice, it demonstrated potential in helping repair brain cells. Researchers are now testing clemastine to determine its safety for babies with these types of injuries.
Clemastine is an antihistamine, commonly used for allergies and generally considered safe. However, in newborns, side effects like restlessness, shaking, and fever have been observed. This trial is in the early stages, so researchers are still assessing how safe and tolerable clemastine is for infants. It is important to note that clemastine is not yet approved for this specific use, and more research is needed to fully understand its safety in this context.12345Why do researchers think this study treatment might be promising?
Clemastine fumarate is unique because it targets white matter injury, a condition usually managed with supportive care and medications focused on symptom relief. Unlike traditional approaches, Clemastine fumarate is believed to promote remyelination, which is the process of repairing the protective sheath around nerve fibers. Researchers are excited about its potential to directly address the underlying damage to white matter, potentially improving neurological function rather than just alleviating symptoms. Its distinct mechanism of action sets it apart from existing treatments, offering new hope for a more effective intervention.
What evidence suggests that clemastine might be an effective treatment for white matter injury?
Research has shown that clemastine fumarate can help form a protective layer around nerve fibers, a process called myelination, in several animal studies. These studies include models that mimic conditions in premature babies. Clemastine improved myelination and aided recovery in these cases by helping oligodendrocytes repair damage to white matter in the brain. While these results are encouraging, most evidence comes from animal studies. This trial will test different dose levels of clemastine fumarate to determine its effects in humans. More research is needed to confirm if these effects occur in humans as well.25678
Who Is on the Research Team?
Bridget Ostrem, MD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for premature infants who have suffered a type of brain injury called white matter injury. The study focuses on babies with acquired brain injuries, including those at risk for cerebral palsy or other related conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral clemastine treatment in a dose-escalation manner to assess safety and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments at 3-5 months, 18 months, and 22-26 months corrected age
What Are the Treatments Tested in This Trial?
Interventions
- Clemastine fumarate
Trial Overview
Researchers are testing the safety and how the body handles an experimental drug called clemastine fumarate when given by mouth to infants with white matter injury. Clemastine is not yet approved for this use.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Dose level 3 (0.05 mg/kg/day)
Dose level 2 (0.03 mg/kg/day)
Dose level 1 (0.01 mg/kg/day)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bridget LaMonica Ostrem, M.D., Ph.D.
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Citations
Minimum effective dose of clemastine in a mouse model of ...
Clemastine at doses of 10 mg/kg/day was further demonstrated to enhance myelination and functional recovery in several animal models of white ...
Minimum Effective Dose of Clemastine in a Mouse Model ...
Clemastine was previously shown to induce oligodendrocyte differentiation and myelination in mouse models of PWMI at a dose of 10 mg/kg/day.
Neonatal White Matter Injury Trial (WRAP)
Clemastine was subsequently shown to promote myelination and improve functional recovery in multiple animal models of WMI, including preterm WMI ...
Minimum effective dose of clemastine in a mouse model ...
Clemastine was previously shown to induce oligodendrocyte differentiation and myelination in mouse models of PWMI at a dose of 10 mg/kg/day. The minimum ...
Clemastine rescues myelination defects and promotes ...
clemastine dramatically promotes oligodendrocyte precursor cell differentiation, myelination, and improves functional recovery. consistent with ...
Clemastine rescues myelination defects and promotes ... - PMC
Clemastine may represent a potential therapy for hypoxic brain injuries associated with white matter injury.
Minimum effective dose of clemastine in a mouse model ...
Clemastine was previously shown to induce oligodendrocyte differentiation and myelination in mouse models of PWMI at a dose of 10 mg/kg/day.
NCT06591091 | Clemastine for Improving White Matter and ...
The goal of this study is to find out if the antihistamine, clemastine, can make the white matter in the brain better in older adults with depression.
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