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

NCT05685225 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Allodynic Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Annette C Toledano, MD · Allodynic Therapeutics, Inc

  • Natalia Belikova, MD PhD · Keystone Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-12-02
Completion
2025-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05685225 on ClinicalTrials.gov