Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia
Status unconfirmed
Conditions studied: Chronic Migraine, Fibromyalgia, New Daily Persistent Headache
In brief
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.
Key facts
- Study ID
- NCT05536050
- Run by
- Thomas Jefferson University
- People needed
- 30
- Starts
- 2022-07-28
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2022-10-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Jefferson Headache Center — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.