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

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia; Chronic Migraine; New Daily Persistent Headache
• Intervention / Treatment: Other: Migraine diary and Questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Jefferson Headache Center
      • Contact: Michael Marmura, MD; Phone Number: 215-955-2243; Email: michael.marmura@jefferson.edu
      • Sub-Investigator: Joshua B Katz, BA
      • Sub-Investigator: Nathalia Figueiredo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be screened and enrolled by study personnel either during their visit with their referring physician, or remotely.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness on migraine	Monthly migraine days	9-12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Headache Disorders, Primary; Headache Disorders; Fibromyalgia; Myofascial Pain Syndromes; Migraine Disorders; Headache
• Other Study ID Numbers: 22D.486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No