Objective:

We aim to assess outcomes of using low-dose naltrexone for chronic migraine in patients with comorbid fibromyalgia.

Background:

Chronic Migraine (CM) often coexists with fibromyalgia (FM). Low-Dose Naltrexone (LDN) administered at doses ranging from 1 to 5 mg blocks mu-opioid receptors, specifically toll-like receptors on glial modulator cells. Previous studies have explored the use of LDN in treating FM. Given the proposed similar pathophysiology in these conditions, our study focuses patients with CM and comorbid FM to analyze the effect of LDN on their headache disorder.

Design/Methods:

This single-center prospective observational study enrolled subjects diagnosed with CM according to the ICHD-3 criteria on stable preventive treatment. Consented patients were screened using the Fibromyalgia Rapid Screening Tool. Eligible patients recorded their baseline headache days for one month before initiating treatment. The primary endpoint was the change in MMD at 12 weeks compared to baseline, while using a daily dose of 4.5 mg of LDN. The secondary endpoint chosen for this abstract was change in MIDAS score at 12 weeks.  Statistical significance was determined using a paired t-test.

Results:

Out of 42 screened patients, 20 were enrolled, with 10 having completed the treatment protocol thus far. The primary endpoint was measured as a percentage over the month based on the day count from each patient's headache diary (28 days vs. 30 days). There were non-significant reductions from 68.07% to 61.62% in MMD (p 0.1277) MIDAS scores (Mean 98.4 at baseline vs. 76.6 at 3 months, p 0.2292) at 12 weeks.

Conclusions:

Results to date have shown improvement in MMD and MIDAS. The lack of statistical significance may be due to a small sample size. This is an ongoing study, and we plan to present final results as we continue to follow up the patients.