Clinical Outcomes From Nalmefene

NCT05808881 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: NAL4001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (1)

• Reversal of Respiratory Depression

  Normalization of the end tidal carbon dioxide value (if measured) to between 35 and 45 mmHg and/or ≥5 breaths per minute increase in respiratory rate from baseline (pre-dose) measurement, with rate of at least 12 breaths per minute.

  Up to 3 hours

Secondary Outcomes (8)

• Time to Reversal from administration of opioid antagonist

  Up to 3 hours

• Recurrence of Respiratory Depression

  Up to 3 hours

• ED Disposition

  Up to 3 hours

• Drug Dosing

  Up to 3 hours

• Richmond-Agitation Sedation Scale (RASS) Score

  Up to 3 hours

Study Arms (2)

Nalmefene

EXPERIMENTAL

Nalmefene hydrochloride (HCl) injection

Drug: Nalmefene Hydrochloride Injection

Naloxone

ACTIVE COMPARATOR

Naloxone hydrochloride (HCl) injection

Drug: Naloxone Hydrochloride Injection

Interventions

Nalmefene Hydrochloride Injection DRUG

for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration

Nalmefene

Naloxone Hydrochloride Injection DRUG

for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration

Also known as: Narcan

Naloxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presumed or known opioid overdose in community settings.
• Experiencing clinically significant respiratory depression based on appropriate medical judgement.
• Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)
• Pre-hospital naloxone administration is allowed.

You may not qualify if:

• Patient age known or estimated to be less than 18 years.
• Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome.
• Cardiac arrest, secondary to opioid intoxication.
• Arrested, jailed, or imprisoned patients.
• Inappropriate for the study per judgement of research team.

Sponsors & Collaborators

• Purdue Pharma LP: lead

MeSH Terms

Conditions

Opiate Overdose

Interventions

nalmefene; Naloxone

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 12, 2023
• Study Start: June 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share