NCT03185143

Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea

Randomized, Double-Blind, and Placebo-Controlled Study to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination Versus Sumatriptan in the Acute Treatment of Migraine With Nausea

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Allodynic Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine.

Detailed description

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

Conditions

• Migraine With and Without Aura

Interventions

Type	Name	Description
DRUG	Naltrexone and Acetaminophen Combination	Treat a single Qualified Migraine attack.
DRUG	Sumatriptan 100 mg	One capsule contains Sumatriptan 100 mg and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.
DRUG	Placebo	One capsule contains a sham for component A and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.

Timeline

• Start date: 2017-06-27
• Primary completion: 2018-05-07
• Completion: 2018-05-07
• First posted: 2017-06-14
• Last updated: 2021-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study