Multi-Center Study of Naltrexone-Acetaminophen in Acute Migraine, With an

Status Not yet recruiting

Clinical Trial Summary

Naltrexone has a dual function as an opioid receptor antagonist and a Toll-Like Receptor-4 (TLR4) antagonist. While primarily approved in a 50 mg tablet for treating opioid and alcohol addiction by blocking opioid receptors, naltrexone's TLR4-blocking effect is also significant. This action reduces the levels of pro-inflammatory cytokines responsible for pain generation, primarily in the trigeminal ganglion and dorsal root ganglia. These sites play a key role in the effectiveness of naltrexone as a pain-alleviating agent. Acetaminophen is the active ingredient in Tylenol, an over-the-counter non-opioid analgesic and antipyretic agent. Both naltrexone and acetaminophen have demonstrated effectiveness in the treatment of acute migraine, physical pain, and emotional pain. However, while naltrexone has demonstrated potential in animal and human studies, confirmatory clinical trials for pain treatment in humans are still lacking. Additionally, it is important to note that around 50% of migraine patients experience co-occurring anxiety. Therefore, this study aims to assess the effectiveness of naltrexone-acetaminophen in treating migraine and co-occurring anxiety compared to each drug alone and placebo. The sponsor has conducted four clinical studies showing promising results of naltrexone-acetaminophen in treating migraine, chronic low-back pain, and emotional pain.

Clinical Trial Description

This study evaluating naltrexone-acetaminophen in acute migraine and co-occurring anxiety in adults lasts between 1.2 to 3.5 months (depending on when a migraine attack is treated during the treatment period). The study includes the following key events: - Screening Visit (Day 1). - 30-day Run-In Period (Days 1-30). - Randomization Visit (Days 31-37). - Treatment Period (Days 31-97): up to 60 days to treat a migraine at home. - End-of-Study Visit (Days 36 -106): 3 to 7 days after treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05685225
Study type	Interventional
Source	Allodynic Therapeutics, Inc
Contact	Annette C Toledano, MD
Phone	3058956808
Email	ctg@allodynic.com
Status	Not yet recruiting
Phase	Phase 2
Start date	July 1, 2024
Completion date	July 1, 2026

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Multi-Center Study of Naltrexone-Acetaminophen in Acute Migraine, With an Exploratory Analysis of Co-occurring Anxiety

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms