This is a multicenter, observational, prospective, real-life study that will be conducted at Headache Centers, aimed at confirming the efficacy and safety of the combination of sumatriptan 85 mg with naproxen 500 mg. The combination of sumatriptan 85 mg and naproxen sodium 500 mg is indicated for the acute treatment of migraine attacks, with or without aura, in adult patients for whom sumatriptan monotherapy is insufficient. In two randomized studies, the sumatriptan/naproxen sodium combination demonstrated significantly greater efficacy (65% of participants-n=1461-reported pain freedom at 2 hours) compared to sumatriptan alone (55%), naproxen sodium alone (44%), or placebo (28%) when used as a late therapy for a single migraine episode in adults. Similar results were observed in a second study (n=1495), with 57% of participants achieving pain freedom within 2 hours after taking the sumatriptan/naproxen sodium combination, outperforming both sumatriptan monotherapy (50%) and naproxen sodium monotherapy (43%), as well as placebo (29%). This superiority was further assessed through sustained pain freedom over 24 hours, with an efficacy of 23-25% in participants treated with the sumatriptan/naproxen combination compared to placebo (7-8%; p\<0.001 for both studies) and its individual components (sumatriptan monotherapy: 14%-16%; p=0.009 and p\<0.001, naproxen sodium monotherapy: 10%).
In four additional randomized studies, the combination was also found to be effective in menstrual migraine and dysmenorrhea, as well as in cases of poor response or intolerance to triptan therapy. In clinical trials, sumatriptan/naproxen sodium was generally well tolerated, with an overall safety profile similar to that of sumatriptan. The most common adverse events were consistent with those expected for sumatriptan and naproxen sodium.
Migraineurs (age ≥18 years, <65 years) with at least 4 migraine days per month according to ICHD-3 criteria who have been prescribed the combination of sumatriptan 85 mg and naproxen 500 mg;
Signed informed consent as required;
Agreement to comply with all study procedures, including follow-up visits;
Use of a contraceptive method by all participants throughout the study duration.
Age <18 years or >65 years
Pregnancy or breastfeeding
Poor knowledge of the Italian language
Comorbidities with other neurological, cardiovascular, hepatic, respiratory, hematological, or autoimmune diseases, or clinically significant laboratory abnormalities
Consecutive adults with episodic migraine (EM) or chronic migraine (CM) with more than 4 days of migraine per month who attend Headache Centers and have been prescribed at least one dose of sumatriptan 85 mg in combination with naproxen 500 mg for the acute treatment of migraine will be enrolled.
Cohort
Prospective
combination of sumatriptan 85 mg and naproxen 500 mg
Drugcombination of sumatriptan 85 mg and naproxen 500 mg
2 hour-pain freedom
Percentage of patients reporting complete pain relief within 2 hours after taking the combination of sumatriptan 85 mg and naproxen 500 mg (2h-pain freedom).
1 hour-pain freedom
Percentage of patients reporting complete pain relief within 1 hour after taking the combination of sumatriptan 85 mg and naproxen 500 mg (1h-pain freedom).
2 hour-pain relief
Percentage of patients reporting a 50% reduction in pain intensity within 2 hours after taking the combination of sumatriptan 85 mg and naproxen 500 mg (2h-pain relief)
Disappearence of Most Bothersome Symptom
Percentage of patients experiencing the disappearance of the Most Bothersome Symptom (MBS: the accompanying symptom of the attack considered most disabling by the patient) within 2 hours after taking the combination tablet of sumatriptan 85 mg/naproxen 500 mg.
Presence or absence of associated symptoms (nausea, vomiting, photophobia, or phonophobia)
Presence or absence of associated symptoms (nausea, vomiting, photophobia, or phonophobia) at predefined time intervals of 1, 2, 3, 4, 6, 8, 24, and 48 hours.
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