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CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome (NOWSHINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04104646
Recruitment Status : Active, not recruiting
First Posted : September 26, 2019
Last Update Posted : December 24, 2019
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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 Syndrome

Condition or disease Intervention/treatment Phase
Neonatal Opioid Withdrawal Syndrome Drug: CHF6563 Drug: Morphine Drug: CHF6563 matched placebo Drug: Morphine matched placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double blind, double-dummy
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : November 14, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CHF6563
Sublingual dose of CHF6563 and the corresponding oral dose of morphine matched placebo
Drug: CHF6563
Sublingual CHF6563 administration at starting dose of 10 µg/Kg q8

Drug: Morphine matched placebo
Oral morphine matched placebo administration

Active Comparator: Morphine
Oral dose of morphine and the corresponding sublingual dose of CHF6563 matched placebo.
Drug: Morphine
Oral morphine administration at starting dose of 0.07 mg/Kg q4

Drug: CHF6563 matched placebo
Sublingual CHF6563 matched placebo administration

Primary Outcome Measures :
  1. Duration of treatment defined as the number of hours from first dose of study drug administration until the last dose of study drug [ Time Frame: up to 10 weeks after first dose ]

Secondary Outcome Measures :
  1. Time to first weaning, defined as the number of hours from first dose of study drug administration until the first dose reduction [ Time Frame: up to 10 weeks after first dose ]
  2. Requirement for adjunctive drug therapy (phenobarbital) for signs of NOWS [ Time Frame: up to 10 weeks after first dose ]
  3. Total hours of treatment with adjunctive therapy [ Time Frame: up to 10 weeks after first dose ]
  4. Requirement for rescue doses (CHF6563 or morphine) [ Time Frame: up to 10 weeks after first dose ]
  5. Percentage of total dose which is from rescue doses [ Time Frame: up to 10 weeks after first dose ]
  6. Length of opioid related hospital stay, defined as number of days from day of birth until 48 hours after the final dose of drug treatment for NOWS [ Time Frame: up to 10 weeks plus 48 hours ]
  7. Relapse of NOWS, defined as experiencing recurrence of significant signs of withdrawal [ Time Frame: up to 6 weeks after last dose ]
  8. Incidence of readmissions, defined as readmission to hospital for NOWS relapse [ Time Frame: up to 6 weeks after last dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04104646

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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19144
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
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Principal Investigator: Walter Kraft Thomas Jefferson University
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Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT04104646    
Other Study ID Numbers: CLI-06563AA1-02
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents