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Topiramate for Hypoxic-Ischemic Encephalopathy

Phase 1 & 2

Waitlist Available

Led By Kristin R Hoffman, MD

Research Sponsored by Kristin R Hoffman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of life 1, 3 and 7

Awards & highlights

Study Summary

This trial is testing whether an anti-epileptic drug can improve the outcome of babies with brain damage caused by lack of oxygen at birth.

Eligible Conditions

Hypoxic-Ischemic Encephalopathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of life 1, 3 and 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of life 1, 3 and 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of life 1, 3 and 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Seizures

Secondary outcome measures

Developmental Outcome

HIE score

MRI score

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TopiramateActive Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Kristin R HoffmanLead Sponsor

Kristin R Hoffman, MDPrincipal Investigator - UC Davis

University of California, Davis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the benefits that patients have found from taking Topiramate?

"Topiramate is an effective medical intervention for hypertension, migraine headaches, and epilepsy."

Answered by AI

How large is the sample size for this research?

"Unfortunately, this particular study is no longer seeking new participants. The trial was first posted on February 1st, 2013 and ended recruitment on March 11th, 2022. However, there are other opportunities available; 690 studies are actively recruiting patients with ischemia while 19 trials for Topiramate are also looking for willing participants."

Answered by AI

Is this research project looking for more participants?

"The aforementioned website indicates that this study is no longer recruiting patients. The original posting was on February 1st, 2013 and the most recent update was on March 11th, 2022. There are 709 other trials currently looking for participants at this time."

Answered by AI

Could you tell me if other researchers have looked into Topiramate?

"Currently, there are 19 ongoing clinical trials studying the efficacy of Topiramate. Of these studies, 3 are in Phase 3. The primary location for these clinical trials is Sherbrooke, Quebec; however, 31 different centres across the globe are running similar investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

Kristin R Hoffman 2013. "Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01765218.