Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

NCT05536050 | Unknown

• 1 other identifier: 22D.486
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine; Fibromyalgia; New Daily Persistent Headache

Outcome Measures

Primary Outcomes (1)

• Effectiveness on migraine

  Monthly migraine days

  9-12 weeks

Secondary Outcomes (7)

• Effectiveness on headache

  9-12 weeks

• Intensity

  9-12 weeks

• The Migraine Disability Assessment Test

  9-12 weeks

• Migraine Specific Quality of Life Index

  9-12 weeks

• Patient Health Questionnaire

  9-12 weeks

Interventions

Migraine diary and Questionnaires OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: July 28, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)