Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPharmazz, Inc.
About this trial
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Either sex with ≥ 36 weeks of gestational age
Receiving supportive management for perinatal asphyxia
Apgar score of <5 at 10 minutes
Need for resuscitation (chest compressions or mechanical ventilation) at birth
Disqualifiers
Gestational age <36 weeks
Admitted to hospital 12-hours after birth
A genetic or congenital condition that affects neuronal development
TORCH infection
Trial design
Design model
Parallel
Treatments tested in this trial
Normal Saline along with standard treatment
DrugSovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.
Sovateltide along with standard treatment
DrugSovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm sovateltide along with standard treatment will be given for active comparison.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Normal Saline + Standard of careActive comparator 1 intervention
Group B: Sovateltide + Standard of careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with death or disability (moderate/severe)
Percentage of patients with death or disability (moderate/severe). Severe disability is defined as any of the following: a Bayley composite cognitive score \<70, a GMFCS grade of level 3 to 5, hearing impairment requiring hearing aids, or blindness (vision \<20/200). Moderate disability is defined as a composite cognitive score 70 - 84, in addition, one or more of the following: GMFCS grade of level 2, unilateral blindness (vision 20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.
Time frame
24 monthsSecondary outcomes
1
Bayley Scales of Infant and Toddler Development Scores
Changes in Bayley Scales of Infant and Toddler Development Scores. Cognitive, Language, Motor, Social-Emotional, and General Adaptive Scales Score as assessed by Bayley Scales of Infant and Toddler Development (BSID)TM measured at 6 months after initiation of treatment and then at every 6 months interval.
Time frame
24 months2
Disabling cerebral palsy
Change in the proportion of children with disabling cerebral palsy
Time frame
24 months3
Seizures
Change in the proportion of patients with seizures. Clinical or electrical seizures at birth, at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 7 days, 30 days, 6 months after initiation of treatment, and then at every 6 months interval.
Time frame
24 months4
Brain injury
The number of patients with brain injury (MRI or EEG evidence of brain injury). Abnormal MRI findings based on NICHD neonatal network score within 1 to 2 weeks of initiation of treatment.
Time frame
14 days]Sponsors and contacts
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Source ClinicalTrials.gov