TerminatedPhase 2

CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

Stopped: Low recruitment rate

United States7 participantsStarted 2020-12-18

Plain-language 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

Who can participate

Age range7 Days

SexALL

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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

What they're measuring

Duration of Treatment

Timeframe: Up to 10 weeks after first dose

Trial details

NCT IDNCT04104646

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-13

Results submitted2022-12-22

View on ClinicalTrials.gov More Neonatal Opioid Withdrawal Syndrome trials