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RLS-0071 for Hypoxic-Ischemic Encephalopathy (STAR Trial)
STAR Trial Summary
This trial studies a new drug to treat hypoxic-ischemic encephalopathy, a condition that affects 4-12k US people each year, and has a high mortality rate. It will evaluate safety and tolerability in newborns with moderate-severe HIE.
STAR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STAR Trial Design
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Who is running the clinical trial?
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- My unborn baby has been diagnosed with a brain issue or hydrocephalus.I have a known major genetic or chromosomal abnormality.I cannot start the study drug within 10 hours of birth.I have severe blood clotting and bleeding issues.I have low blood pressure that doesn't improve with medication.I need advanced support to breathe despite receiving 100% oxygen.My head circumference is less than 30 cm.My infant might have a severe infection or was born with an infection.My newborn has brain dysfunction not caused by birth-related oxygen deprivation.I am eligible for cold temperature treatment.I have moderate or severe confusion due to liver problems.My baby started whole-body cooling before 6 hours old.My birth weight was 1800 g or less.
- Group 1: RLS-0071
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are recruitment efforts for this trial currently underway?
"Indeed, clinicaltrials.gov reports that this trial is actively searching for participants. It was first published on the 27th of July and most recently updated on August 4th 2023."
What deleterious effects have been linked to RLS-0071 on patients?
"While there is some evidence demonstrating the safety of RLS-0071, no studies have been conducted to vouch for its effectiveness. Consequently, our team at Power estimates that this medication's safety rating lies somewhere between 1 and 3."
How many locales are managing this research?
"Patients are able to participate in this medical research at Study Site 002 located in Boston, Massachusetts; Study Site 006 situated in Saint Louis, Missouri; and Study Site 003 which is based out of Durham, North carolina. Additionally, there are 5 other locations where enrolment is possible."
What is the quota of individuals being enrolled in this research?
"Affirmative. On clinicaltrials.gov, the latest information indicates that this medical research is actively enrolling volunteers. First posted on July 27th 2023 and last updated four days later, it requires 42 participants to be recruited from 5 different locations."
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