NCT05685225

Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial

Safety and Efficacy of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Single-Site, Phase 2 Randomized Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allodynic Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

* This two-stage clinical trial will assess a novel combination therapy for acute migraine. In Stage 1 (factorial), participants will receive the combination, each individual component, or placebo. In Stage 2 (dose-finding), they will test three doses of the combination. Before both stages, participants will complete a run-in period, documenting a migraine attack without study medication. They will then treat one migraine attack in each stage. * 4 visits * Requirements: Migraine Diagnosis. BMI below 34. Read, write, and speak English. No opioids, marijuana, benzodiazepines, or excessive alcohol.

Detailed description

This study evaluating naltrexone-acetaminophen in the acute treatment of migraine.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Stage 1: Naltrexone/Acetaminophen	Combination
DRUG	Stage 1: Naltrexone	Naltrexone alone
DRUG	Stage 1: Acetaminophen	Acetaminophen alone
DRUG	Stage1: Placebo	Matching placebo
DRUG	Stage 2: Naltrxone/Acetaminophen high dose	Combination high dose
DRUG	Stage 2: Naltrexone/Acetaminophen medium dose	Combination medium dose
DRUG	Stage 2: Naltrxone/Acetaminophen low dose	Combination low dose
DRUG	Stage 2: Placebo	Matching Placebo

Timeline

• Start date: 2025-01-31
• Primary completion: 2025-12-02
• Completion: 2025-12-02
• First posted: 2023-01-17
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study