An observational study in Chronic Migraine, Fibromyalgia and New Daily Persistent Headache, sponsored by Thomas Jefferson University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Thomas Jefferson University · Observational
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 270 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be screened and enrolled by study personnel either during their visit with their referring physician, or remotely.
Exclusion Criteria:
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.
Effectiveness on migraine
Monthly migraine days
Time frame: 9-12 weeks
Effectiveness on headache
Monthly headache days
Time frame: 9-12 weeks
Intensity
Average peak intensity of migraine
Time frame: 9-12 weeks
The Migraine Disability Assessment Test
Impact of migraine on daily life
Time frame: 9-12 weeks
Migraine Specific Quality of Life Index
Impact of migraine and migraine treatment on quality of life
Time frame: 9-12 weeks
Patient Health Questionnaire
Monitor depression and changes in signs/symptoms of depression
Time frame: 9-12 weeks
Fibromyalgia Impact Questionnaire
Assess health status of patients with fibromyalgia
Time frame: 9-12 weeks
Patients' Global Impression of Change
Assess patient's belief in efficacy of treatment
Time frame: 9-12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University