CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Morphine

Criteria

Inclusion Criteria:

1. Written informed consent obtained by parents/legal representative(according to local regulation) prior to or after birth.

2. Birth weight ≥ 3rd centile for gestational age (GA), according to the CDC growth chart

3. Gestational age ≥ 36 weeks

4. Exposure to opioids during the last month of fetal life

5. Signs of neonatal opioid withdrawal syndrome requiring treatment, and the sum of 3 consecutive FNAST scores is ≥ 24 or a single score ≥ 12

Exclusion Criteria:

1. Familial history of prolonged QTc syndrome

2. Major congenital malformations or evidence of congenital infection

3. Signs of fetal alcohol spectrum disorders

4. Maternal alcohol abuse, defined as average of 3 or more drinks per week in the last 30 days

5. Medical illness at the time of randomization, including but not exclusively:

1. Neonatal hypoglycemia requiring intravenous glucose therapy

2. Neonatal respiratory illness requiring non-invasive or invasive respiratory support

3. Neonatal encephalopathy (including hypoxic ischemic encephalopathy or seizures

4. Severe hyperbilirubinemia-bilirubin at or above the exchange transfusion threshold as defined by the AAP

5. Severe elevation of serum aminotransferases (more than twice the upper limit of the age appropriate aminotransferases reference range of the investigational site).

6. Proven or suspected early onset neonatal infection which will require more than 48hours treatment with antibiotics

6. Unable to tolerate an oral or sublingual medication

7. Need for medications forbidden in this study protocol

8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

9. Participation in another clinical trial of any medicinal product, placebo, experimental medical device or biological substance conducted under the provisions of a protocol on the same therapeutic target. The participation in studies involving diagnostic devices or treatments for conditions other than NOWS and NAS may be permitted following an agreement with the Sponsor. Non-interventional observational studies are allowed