Status:
TERMINATED
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Neonatal Opioid Withdrawal Syndrome
Eligibility:
All Genders
Up to 7 years
Phase:
PHASE2
Brief 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 Syndro...
Detailed Description
This was a randomised, multicentre, double-blind, double-dummy, parallel-group, controlled study of CHF6563 (non-ethanolic buprenorphine) sublingual solution. For the enrolled subjects, withdrawal si...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04104646
Start Date
December 18 2020
End Date
December 13 2021
Last Update
August 3 2023
Active Locations (2)
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1
Clinical site 015
Las Vegas, Nevada, United States, 89102
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19144