Fibromyalgia Clinical Trial
Official title:
Prospective Observational Pilot Study of Low-dose Naltrexone in Patients With Chronic Migraine With Comorbid Fibromyalgia
NCT number | NCT05536050 |
Other study ID # | 22D.486 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 28, 2022 |
Est. completion date | December 2023 |
Verified date | October 2022 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Jefferson Headache Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
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 |
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