CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Neonatal Opioid Withdrawal Syndrome

In brief

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

Key facts

Study ID

NCT04104646

Run by

Chiesi Farmaceutici S.p.A.

People needed

7

Starts

2020-12-18

Expected to finish

2021-12-13

Last updated by the study team

2023-08-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent obtained by parents/legal representative(according to local regulation) prior to or after birth.
• Birth weight ≥ 3rd centile for gestational age (GA), according to the Centers for Disease Control and Prevention (CDC) growth chart
• Gestational age ≥ 36 weeks
• Exposure to opioids during the last month of fetal life
• Signs of neonatal opioid withdrawal syndrome requiring treatment, and the sum of 3 consecutive FNAST scores is ≥ 24 or a single score ≥ 12

You may not qualify if…

• Familial history of prolonged QTc syndrome
• Major congenital malformations or evidence of congenital infection
• Signs of fetal alcohol spectrum disorders
• Maternal alcohol abuse, defined as average of 3 or more drinks per week in the last 30 days
• Medical illness at the time of randomization, including but not exclusively:
• Neonatal hypoglycemia requiring intravenous glucose therapy
• Neonatal respiratory illness requiring non-invasive or invasive respiratory support
• Neonatal encephalopathy (including hypoxic ischemic encephalopathy or seizures
• Severe hyperbilirubinemia-bilirubin at or above the exchange transfusion threshold as defined by the American Academy of Pediatrics (AAP)
• Severe elevation of serum aminotransferases (more than twice the upper limit of the age appropriate aminotransferases reference range of the investigational site).
• Proven or suspected early onset neonatal infection which will require more than 48 hours treatment with antibiotics
• Unable to tolerate an oral or sublingual medication
• Need for medications forbidden in this study protocol
• Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
• 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 Neonatal abstinence syndrome (NAS) may be permitted following an agreement with the Sponsor. Non-interventional observational studies are allowed

Where it is running

• Clinical site 015 — Las Vegas, Nevada, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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