A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0… (NCT05778188) | Clinical Trial Compass
RecruitingPhase 2
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
United States70 participantsStarted 2023-07-27
Plain-language summary
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 participate
Age range10 Hours
SexALL
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Inclusion criteria
✓. ≥ 36 weeks gestation.
✓. Sentinel event prior to delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse or other acute event likely attributable for newborn depression at delivery or an acute change in the fetal status with a clinical presentation consistent with an acute sentinel event with no clearly defined etiology.
✓. Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b):
✓. Risk of encephalopathy (either):
✓. Clinical signs of encephalopathy (either/both):
✓. Be eligible to receive therapeutic hypothermia.
✓. Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling).
✓. Product of a singleton pregnancy.
Exclusion criteria
✕
What they're measuring
1
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment group at Day 14
Timeframe: Day 1 to Day 14
2
Frequency and severity of events of special interest and SAEs by treatment group at 24 months
Timeframe: Day 1 to 24 months
3
Frequency of premature discontinuation by treatment group due to AEs at Day 14
Timeframe: Day 1 to Day 14
4
Acute brain injury at Day 4, assessed through magnetic resonance imaging (MRI), using a standardized scoring system
Timeframe: Day 4
5
Acute brain injury at Day 12, assessed through magnetic resonance imaging (MRI), using a standardized scoring system