CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

Study Identifier:
CLI-06563AA1-02
ClinicalTrials.gov Identifier:
NCT04104646
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn

Trial Documents

Protocol
Available Languages: English
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Statistical Analysis Plan
Available Languages: English
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Plain Language Summary
Available Languages: English
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Study Details

Medical Condition
  • Neonatal Opioid Withdrawal Syndrome
Study Drug
  • Drug: CHF6563
  • Drug: Morphine
  • Drug: CHF6563 matched placebo
  • Drug: Morphine matched placebo
Date
Dec 2020 - Dec 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - 7 Days
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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
Healthy Volunteers
No

Protocol 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

Study Locations

Location
Status
Location
Clinical site 015
Las Vegas, Nevada, United States, 89102
Status
N/A
Location
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19144
Status
N/A