NCT03061734

Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine

A Clinical Trial to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Allodynic Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing.

Conditions

• Migraine With or Without Aura

Interventions

Type	Name	Description
DRUG	Naltrexone and Acetaminophen	Naltrexone plus acetaminophen
DRUG	Naltrexone and Acetaminophen-High Dose	Naltrexon (high dose) plus acetaminophen
DRUG	Naltrexone Alone (regular dose)	Naltrexone Alone plus Placebo
DRUG	Acetaminophen Alone	Acetaminophen Alone plus Placebo
DRUG	Matching Placebo	Two Placebo capsules

Timeline

• Start date: 2017-02-18
• Primary completion: 2018-02-08
• Completion: 2018-02-08
• First posted: 2017-02-23
• Last updated: 2021-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study