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Tests treatment safety and results for Hypoxic-Ischemic Encephalopathy
Official title Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
ClinicalTrials.gov ID: NCT05514340
What this study is testing
What is Normal Saline along with standard treatment?
Normal Saline along with standard treatment is an investigational medicine, being studied as a potential treatment for hypoxic-ischemic encephalopathy.
Also referred to as Vehicle.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Either sex with ≥ 36 weeks of gestational age
- Receiving supportive management for perinatal asphyxia
- Perinatal depression, based on at least one of the following:
- Apgar score of \<5 at 10 minutes
- Need for resuscitation (chest compressions or mechanical ventilation) at birth
You likely can't join if
- Gestational age \<36 weeks
- Admitted to hospital 12-hours after birth
- A genetic or congenital condition that affects neuronal development
- TORCH infection
- Neonatal sepsis
- Complex congenital heart disease
See the full eligibility criteria
- Either sex with ≥ 36 weeks of gestational age
- Receiving supportive management for perinatal asphyxia
- Perinatal depression, based on at least one of the following:
- Apgar score of \<5 at 10 minutes
- Need for resuscitation (chest compressions or mechanical ventilation) at birth
- pH \<7.00 or base deficit ≥ 16 mmol/liter in the cord or arterial blood within 60 minutes of birth
- Moderate/severe encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.
- Informed consent by one of the parents or a legal representative
- Gestational age \<36 weeks
- Admitted to hospital 12-hours after birth
- A genetic or congenital condition that affects neuronal development
- TORCH infection
- Neonatal sepsis
- Complex congenital heart disease
- Severe dysmorphic feature
- Microcephaly (head circumference \< 2 Standard Deviations below mean for gestational age)
The study team makes the final eligibility decision.
Where it's taking place
- Mangalore, Karnataka, India
- Ludhiana, Punjab, India
- Hyderabad, Telangana, India
- Kanpur, Uttar Pradesh, India
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mangalore, Karnataka, India; Ludhiana, Punjab, India; Hyderabad, Telangana, India; Kanpur, Uttar Pradesh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.