Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05536050
• Other study ID #: 22D.486
• Status: Recruiting
• Start date: July 28, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Fibromyalgia
• Headache
• Migraine Disorders
• Myofascial Pain Syndromes
• New Daily Persistent Headache

Intervention

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.

Locations

Country	Name	City	State
United States	Jefferson Headache Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

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