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

> **NCT05685225** · PHASE2 · WITHDRAWN · sponsor: **Allodynic Therapeutics, Inc**

## Conditions studied

- Migraine

## Interventions

- **DRUG:** Stage 1: Naltrexone/Acetaminophen
- **DRUG:** Stage 1: Naltrexone
- **DRUG:** Stage 1: Acetaminophen
- **DRUG:** Stage1: Placebo
- **DRUG:** Stage 2: Naltrxone/Acetaminophen high dose
- **DRUG:** Stage 2: Naltrexone/Acetaminophen medium dose
- **DRUG:** Stage 2: Naltrxone/Acetaminophen low dose
- **DRUG:** Stage 2: Placebo

## Key facts

- **NCT ID:** NCT05685225
- **Lead sponsor:** Allodynic Therapeutics, Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2025-01-31
- **Primary completion:** 2025-12-02
- **Final completion:** 2025-12-02
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** No participants enrolled; study suspended due to recruitment challenges.
- **Last updated:** 2025-12-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05685225

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05685225, "Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT05685225. Licensed CC0.

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