A Phase 1/2 interventional study of Topiramate and Placebo in Hypoxic Ischemic Encephalopathy, sponsored by Kristin R Hoffman. Terminated at 1 site in United States. Open to participants aged Up to 6 Hours. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Kristin R Hoffman · Phase 1/2, Interventional, and Treatment
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
Hypoxic ischemic encephalopathy (HIE) is a devastating and unexpected disease in newborns that affects 1.5-2.6 per 1000 live births. Hypoxic ischemic encephalopathy has a mortality rate of up to 30% and survivors are at significant risk for adverse long-term outcomes, including seizures, cerebral palsy, and developmental delay. The investigators propose a randomized controlled study comparing therapeutic hypothermia alone, or therapeutic hypothermia combined with topiramate. The investigators hypothesize that adjuvant therapy with topiramate will reduce short term severity of HIE including seizures (the primary outcome), a composite HIE severity score, and reduce the time of normalization of the amplitude integrated EEG (aEEG). The investigators further hypothesize, that it will improve longer term outcomes such as developmental outcome. The primary hypothesis is that seizures before hospital discharge (or before 4 weeks post-natal age (which ever is earlier)) will be significantly reduced in the topiramate group compared to the control group
758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.
This study's enrollment of 34 is below the median of 58 across 454 interventional studies indexed under Brain Diseases.
Browse Brain Diseases studies →This is the only study on the registry with Kristin R Hoffman as lead sponsor.
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In order to be eligible for cooling the baby must meet all three of the following sets of criteria
Exclusion Criteria:
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
Drug: Placebo
In addition to whole body cooling, infants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.
Drug: Topiramate
Infants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.
Also known as: Topamax, Topiragen
A placebo identical in appearance to the active agent (topiramate)
Number of Patients With Seizures
Clinical or electrical seizures occuring before hospital discharge or before 4w post-natal age (which ever is earlier) will be compared between the topiramate and control groups.
Time frame: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier)
| Milestone | Placebo | Topiramate |
|---|---|---|
| Started | 17 | 17 |
| Completed | 16 | 15 |
| Not completed | 1 | 2 |
| Withdrew: Protocol violation | 1 | 2 |
Clinical or electrical seizures occuring before hospital discharge or before 4w post-natal age (which ever is earlier) will be compared between the topiramate and control groups.
| Participants with Seizures | Placebo | Topiramate |
|---|---|---|
| Number of Patients With Seizures | 3 | 1 |
Collected over Data was collected until discharge, typically less than one month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 1/17 (5.9%) | 1/17 (5.9%) | 2/17 (11.8%) |
| Topiramate | 0/17 (0%) | 0/17 (0%) | 4/17 (23.5%) |
| Event | Placebo | Topiramate |
|---|---|---|
| SepsisInfections and infestations | 1/17 | 0/17 |
| Necrotizing EnterocolitisGastrointestinal disorders | 0/17 | 0/17 |
| Chronic Lung DiseaseRespiratory, thoracic and mediastinal disorders | 0/17 | 0/17 |
| Event | Placebo | Topiramate |
|---|---|---|
| Need for Bicarbonate or THAM for acidosisGeneral disorders | 2/17 | 3/17 |
| Need for Bronchodilator TherapyRespiratory, thoracic and mediastinal disorders | 0/17 | 1/17 |
| Age, Customized(Weeks) | Placebo | Topiramate | Total |
|---|---|---|---|
| Gestational Age | 39.12 (37 to 40.71) | 38.88 (36.14 to 41.29) | 39 (36.14 to 41.29) |
| Sex: Female, Male(Participants) | Placebo | Topiramate | Total |
|---|---|---|---|
| Female | 10 | 5 | 15 |
| Male | 7 | 12 | 19 |
| Race (NIH/OMB)(Participants) | Placebo | Topiramate | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 5 | 10 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 6 | 8 | 14 |
| Birth Weight (g)(grams) | Placebo | Topiramate | Total |
|---|---|---|---|
| Mean | 3236.14 (2100 to 4580) | 3159.24 (2200 to 5520) | 3197.46 (2100 to 5520) |
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