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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness on migraine | Monthly migraine days | 9-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness on headache | Monthly headache days | 9-12 weeks |
| Intensity | Average peak intensity of migraine | 9-12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be screened and enrolled by study personnel either during their visit with their referring physician, or remotely.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Headache Center | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| The Migraine Disability Assessment Test | Impact of migraine on daily life | 9-12 weeks |
| Migraine Specific Quality of Life Index | Impact of migraine and migraine treatment on quality of life | 9-12 weeks |
| Patient Health Questionnaire | Monitor depression and changes in signs/symptoms of depression | 9-12 weeks |
| Fibromyalgia Impact Questionnaire | Assess health status of patients with fibromyalgia | 9-12 weeks |
| Patients' Global Impression of Change | Assess patient's belief in efficacy of treatment | 9-12 weeks |
| D009422 |
| Nervous System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |