← Back to Search

Alcohol Dehydrogenase Inhibitor

Fomepizole for Acetaminophen Overdose

Phase 2
Recruiting
Research Sponsored by Richard Dart, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up fomepizole serum concentration will be measured at 2, 5, 12, 20, 32, 44, etc. hours after starting nac (and every 12 hours afterwards) as long as patient is receiving medication (either nac or nac and 4-mp), two to three days on average.
Awards & highlights

Study Summary

This trial will test if a combo of two drugs can help prevent liver injury in acetaminophen poisoning. Primary goal is to measure effect of one drug on severity of injury.

Who is the study for?
This trial is for people aged 10 or older who have taken too much acetaminophen and are at risk of liver injury. They must have a certain level of acetaminophen in their blood and be admitted to the hospital. Pregnant women, those with severe liver damage, recent seizures, heart issues, or other serious health problems can't join.Check my eligibility
What is being tested?
The study tests if adding Fomepizole (4-MP) to the standard treatment with N-acetylcysteine (NAC) is better for treating acetaminophen overdose than using NAC alone. Participants will receive either both drugs or just NAC through an IV in this randomized and blinded trial.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the medications used, irritation at the infusion site, headache, dizziness, nausea, changes in blood pressure or heart rate. The severity of side effects may vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~protein adducts will be measured at 2, 5, 12, 20, 32, 44, etc. hours after starting nac (and every 12 hours afterwards) as long as patient is receiving medication (either nac or nac and 4-mp), two to three days on average.
This trial's timeline: 3 weeks for screening, Varies for treatment, and protein adducts will be measured at 2, 5, 12, 20, 32, 44, etc. hours after starting nac (and every 12 hours afterwards) as long as patient is receiving medication (either nac or nac and 4-mp), two to three days on average. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in serum ALT from presentation to peak recorded ALT
Secondary outcome measures
Measurement of protein adducts
Peak AST
International Normalized Ratio
+4 more
Other outcome measures
Measurement to perform a candidate gene analysis of CYP2E1, glutathione synthetase, UDP-glucuronosyltransferases, JNK related to APAP toxicity.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: N-acetylcysteine (NAC) and Fomepizole (4-MP) (Study)Experimental Treatment2 Interventions
Patients randomized to Study group will receive fomepizole (diluted in D5W) in addition to N-acetylcysteine. Study participants will receive study drug (fomepizole or placebo) throughout the study. If randomized to Study group, the infusion of the study medication should be initiated as soon as feasible but no later than 24 hours after the commencement of acetylcysteine therapy.
Group II: N-acetylcysteine (NAC) only (Control)Active Control1 Intervention
Patients randomized to Control group will receive placebo (D5W) in addition to N-acetylcysteine. Study participants will receive study drug (fomepizole or placebo) throughout the study.

Find a Location

Who is running the clinical trial?

Richard Dart, MD, PhDLead Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionIndustry Sponsor
8 Previous Clinical Trials
2,425 Total Patients Enrolled

Media Library

Fomepizole (4-MP) (Alcohol Dehydrogenase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05517668 — Phase 2
Acetaminophen Overdose Research Study Groups: N-acetylcysteine (NAC) and Fomepizole (4-MP) (Study), N-acetylcysteine (NAC) only (Control)
Acetaminophen Overdose Clinical Trial 2023: Fomepizole (4-MP) Highlights & Side Effects. Trial Name: NCT05517668 — Phase 2
Fomepizole (4-MP) (Alcohol Dehydrogenase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05517668 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ultimate purpose is this medical experiment attempting to achieve?

"This clinical trial's primary aim is to gauge the difference between baseline alanine aminotransferase (ALT) levels and peak ALT measurements as taken over a period of two to three days. Secondary objectives include measuring acetylcysteine infusion endpoints, peak AST values, and protein adduct concentrations in order toevaluate the efficacy of fomepizole for reducing CYP2E1 inhibition."

Answered by AI

Does this research program admit participants aged 55 or older?

"This research endeavor is recruiting participants aged 18 or over, up to the age of 99."

Answered by AI

What is the capacity of this trial?

"Affirmative, according to the clinicaltrials.gov website, this trial is actively recruiting patients from a single centre. This medical study was posted on September 12th 2022 and subsequently updated October 21st of that same year with an aim to enroll 40 participants."

Answered by AI

What effects, if any, have been documented when using N-acetylcysteine (NAC) and Fomepizole (4-MP)?

"As this is a Phase 2 study without any efficacy data, Power assigns N-acetylcysteine (NAC) and Fomepizole (4-MP)'s safety score as a 2."

Answered by AI

Are volunteers currently being accepted for this clinical research?

"Confirmed, the clinical trial is openly recruiting across 1 sites. The study was initially announced on September 12th 2022 and has since been amended on October 21st of the same year. 40 patients are needed to participate in this medical experiment."

Answered by AI

What type of patient is best suited for participating in this medical experiment?

"40 adults between 18 and 99 years of age who have ingested acetaminophen are being enrolled in this research trial. To qualify for the study, participants must provide written agreement to take part (informed consent), possess serum levels of acetaminophen at or above 10mg/L after bilirubin correction is applied, demonstrate baseline AT Multiplication Product values higher than 1500, report any recent ingestion within 8 hours prior to screening tests taking place, be willing to comply with all procedures outlined by the study protocol, agree to receive hospital-based treatment or emergency care if needed and remain available until completion of the entire trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
Richard Dart, MD, PhD 2022. "Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517668.
~18 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top