Common allergy drug may heal brain damage in preterm infants

NCT ID NCT07688746

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 07, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study tests whether clemastine, an allergy medicine, is safe for premature babies with white matter injury—a common brain injury in infants born early. Researchers will give the drug by mouth to 24 babies born at or before 32 weeks and now between 35 and 41 weeks old. The goal is to check for side effects and learn how the drug moves through their bodies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
clemastine (an antihistamine drug)
What this could lead to
If safe, this could point toward a treatment to repair brain damage in premature infants.
What could go wrong
This is an early, small safety study in 24 babies, so it may not show benefit or could reveal unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 20 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

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