NCT05536050

Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

Prospective Observational Pilot Study of Low-dose Naltrexone in Patients With Chronic Migraine With Comorbid Fibromyalgia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.

Conditions

• Chronic Migraine
• Fibromyalgia
• New Daily Persistent Headache

Interventions

Type	Name	Description
OTHER	Migraine diary and Questionnaires	Patients who already have a prescription for low-dose naltrexone will be administered questionnaires twice during the trial. Additionally, patients will maintain migraine diary for the duration of the trial.

Timeline

• Start date: 2022-07-28
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-09-10
• Last updated: 2022-10-27

Locations

1 site across 1 country: United States