Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

Recruiting

• Conditions: Fibromyalgia; Chronic Migraine; New Daily Persistent Headache

• Registration Number: NCT05536050
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-28
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects will be adults of all genders ages 18 and older.
• Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist.
• Subjects who received a new prescription for LDN
• Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool
• Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months.
• Subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice.
• Subjects willing to fill out pre and post intervention surveys
• Subjects willing to comply with planned follow up phone calls and visits.

Exclusion Criteria

• Not planning on follow up care with clinician.
• Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness on migraine	9-12 weeks	Monthly migraine days

Secondary Outcome Measures

Name	Time	Method
Intensity	9-12 weeks	Average peak intensity of migraine
The Migraine Disability Assessment Test	9-12 weeks	Impact of migraine on daily life
Patient Health Questionnaire	9-12 weeks	Monitor depression and changes in signs/symptoms of depression
Effectiveness on headache	9-12 weeks	Monthly headache days
Patients' Global Impression of Change	9-12 weeks	Assess patient's belief in efficacy of treatment
Migraine Specific Quality of Life Index	9-12 weeks	Impact of migraine and migraine treatment on quality of life
Fibromyalgia Impact Questionnaire	9-12 weeks	Assess health status of patients with fibromyalgia

Trial Locations

Locations (1)

Jefferson Headache Center; 🇺🇸 Philadelphia, Pennsylvania, United States