NCT05685225View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Migraine
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

Trial Locations (1)

33181

RECRUITING

Keystone Clinical Research, North Miami

Sponsors
All Listed Sponsors
lead

Allodynic Therapeutics, Inc

INDUSTRY

NCT05685225 - Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial | Biotech Hunter | Biotech Hunter