Clemastine for Neonatal White Matter Injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/Ib open-label study evaluates the safety and pharmacokinetics of oral clemastine in neonates with preterm white matter injury. Eligible infants are born at or before 32 weeks gestation, are 35–41 weeks postmenstrual age, and have imaging-confirmed white matter injury while in a participating NICU. The trial uses a dose-escalation and dose-expansion design to identify safe dosing and characterize how clemastine is absorbed, distributed, metabolized, and eliminated in this population. Primary goals are to assess safety and pharmacokinetics; exploratory aims may inform future studies on potential myelination effects. The study is sponsored by an individual investigator with NINDS collaboration and is conducted at UC San Francisco.

Why it matters

Who can join: the full rules

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 disorder or major congenital anomalies
2. Major intracranial hemorrhage within the last 1 week or intracranial hemorrhage of any age that is not controlled or continuing to cause significant mass effect or midline shift.
3. History of cardiac arrhythmia or current ongoing tachycardia with baseline heart rate \>10% age expected norms.
4. Hypotension requiring ongoing vasopressor or inotropic support.
5. Not able to receive enteral medications.
6. Clinically significant sedation due to critical illness or medications.
7. Concomitant use of any other putative neuroprotective or myelination promoting therapy as determined by the investigator.
8. Serum creatinine, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \>2x the upper limit of normal for age.
9. Family history of epilepsy due to a confirmed or suspected genetic cause.
10. History of confirmed seizure activity.
11. If ≥36 weeks postmenstrual age, required respiratory support greater than 2L/min, noninvasive positive airway pressure, or mechanical ventilation upon reaching 36 weeks postmenstrual age due to diagnosis of moderate or severe BPD.
12. If less than 36 weeks postmenstrual age, currently requiring respiratory support greater than 2L/min, noninvasive positive airway pressure, or mechanical ventilation, unless respiratory support is being given to promote lung development and not due to clinical need.
13. Major medical conditions, laboratory abnormalities, or concurrent treatments that, in opinion of the investigator, may affect interpretation of study results or patient safety.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Bridget Ostrem, MD, PhD — University of California, San Francisco
• Study coordinator: Audrey Hernando, BS
• Email: audrey.hernando@ucsf.edu
• Phone: 415-502-2425

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.