Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

Last updated: October 25, 2022
Sponsor: Thomas Jefferson University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Migraine And Cluster Headaches

Pain

Headaches

Treatment

N/A

Clinical Study ID

NCT05536050
22D.486
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 bya 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 monthswith no plans to change medication for the next 4 months.
  • Subjects willing to maintain a headache/migraine diary one month prior to takingmedication and while taking the medication, either physical or electronic diary oftheir choice.
  • Subjects willing to fill out pre and post intervention surveys
  • Subjects willing to comply with planned follow up phone calls and visits.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 30
Study Start date:
July 28, 2022
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Jefferson Headache Center

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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