NOWSHINE: CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome

• Sponsor: Chiesi Farmaceutici S.p.A. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04104646
• Collaborator: (none)
• Enrollment: 16
• Locations: 2
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site: 8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 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: Jan 26, 2021
• Actual Primary Completion Date: Dec 8, 2021
• Actual Study Completion Date: Dec 8, 2021

Arms and Interventions

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

Outcome Measures

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 [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 [up to 10 weeks after first dose]

2. Requirement for adjunctive drug therapy (phenobarbital) for signs of NOWS [up to 10 weeks after first dose]

3. Total hours of treatment with adjunctive therapy [up to 10 weeks after first dose]

4. Requirement for rescue doses (CHF6563 or morphine) [up to 10 weeks after first dose]

5. Percentage of total dose which is from rescue doses [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 [up to 10 weeks plus 48 hours]

7. Relapse of NOWS, defined as experiencing recurrence of significant signs of withdrawal [up to 6 weeks after last dose]

8. Incidence of readmissions, defined as readmission to hospital for NOWS relapse [up to 6 weeks after last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 7 Days
• 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:

6. Neonatal hypoglycemia requiring intravenous glucose therapy

7. Neonatal respiratory illness requiring non-invasive or invasive respiratory support

8. Neonatal encephalopathy (including hypoxic ischemic encephalopathy or seizures

9. Severe hyperbilirubinemia-bilirubin at or above the exchange transfusion threshold as defined by the AAP

10. Severe elevation of serum aminotransferases (more than twice the upper limit of the age appropriate aminotransferases reference range of the investigational site).

11. Proven or suspected early onset neonatal infection which will require more than 48hours treatment with antibiotics

12. Unable to tolerate an oral or sublingual medication

13. Need for medications forbidden in this study protocol

14. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

15. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical site 015	Las Vegas	Nevada	United States	89102
2	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19144

Sponsors and Collaborators

• Chiesi Farmaceutici S.p.A.

Investigators

• Principal Investigator: Walter Kraft, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chiesi Farmaceutici S.p.A.
• ClinicalTrials.gov Identifier: NCT04104646
• Other Study ID Numbers: CLI-06563AA1-02
• First Posted: Sep 26, 2019
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Syndrome; Substance Withdrawal Syndrome; Morphine

Study Results

No Results Posted as of Mar 28, 2022