A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia (NCT05778188)
A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia With Long-Term Follow-Up
🩺 Plain-English Summary (8th-Grade Level)
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.
Who can join: Review the eligibility criteria below.
Location: Study Site 016 — Little Rock, Arkansas
Age range: Not specified to 10 Hours
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Study Site 016 — Little Rock, Arkansas
- Study Site 013 — Orange, California
- Study Site 020 — San Diego, California
- Study Site 019 — San Diego, California
- Study Site 001 — Gainesville, Florida
- Study Site 018 — Miami, Florida
- Study Site 010 — Orlando, Florida
- Study Site 014 — Indianapolis, Indiana
- Study Site 012 — Lexington, Kentucky
- Study Site 002 — Boston, Massachusetts
- Study Site 006 — St Louis, Missouri
- Study Site 003 — Durham, North Carolina
- Study Site 021 — Cleveland, Ohio
- Study Site 022 — Fort Worth, Texas
- Study Site 005 — Morgantown, West Virginia
📞 Contact the Study Coordinator
Phone: (757) 901-0331
Email: Lupham@realtals.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hypoxic-Ischemic Encephalopathy
- Dose Optimization of Caffeine for HIE — Chapel Hill, North Carolina
- Healthy Little Eyes — Madison, Wisconsin
- Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit — Montreal, Quebec
Explore by condition: All Hypoxic-Ischemic Encephalopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.