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.
Consecutive episodic or chronic migraine adults (with more than 4 migraine days per month) followed at the Headache Centers and have been prescribed at least one dose of sumatriptan 85 mg in combination with naproxen sodium 500 mg for the acute treatment of migraine will be enrolled. The collection of demographic and clinical characteristics will be carried out through a direct interview using a detailed, semi-structured questionnaire during the screening/baseline visit, when the prescription of the sumatriptan 85 mg and naproxen sodium 500 mg combination for migraine attacks will be issued. The follow-up visit will occur after 12 weeks (+/-14 days) from the screening/baseline visit, the end of study visit will take place after 24 weeks (+/-14 days) from baseline. Patients will be provided with paper diaries for the following 12 weeks at screning/baseline visit and at the follow up visit (at week 12). The paper diaries from the previous 12 weeks will be collected will be collected at week 12 and at week 24. The following questionnaires will be administered: * Migraine Specific Quality of Life Questionnaire (MSQ) * Migraine Interictal Burden Scale (MIBS-4) * Headache Impact Test-6 (HIT-6) were administered at baseline/screening visit, at follow-up visit (at week 12) and at the end of study visit. Throughout the study, any adverse events will be recorded and managed.
Study Type
OBSERVATIONAL
Enrollment
300
combination 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).
Time frame: 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
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).
Time frame: 1 hour after taking combination of sumatriptan 85 mg and naproxen 500 mg
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)
Time frame: 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
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.
Time frame: 2 hours after taking combination of sumatriptan 85 mg and 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.
Time frame: 1-48 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
24 hour-sustained pain freedom
Percentage of patients experiencing complete pain relief within 2 hours after taking the combination of sumatriptan 85 mg and naproxen 500 mg, with sustained benefit in the following 24 hours (24h-sustained pain freedom).
Time frame: 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
24 hour sustained pain relief
Percentage of patients experiencing a 50% reduction in pain intensity within 2 hours after taking the combination of sumatriptan 85 mg and naproxen 500 mg, with sustained benefit in the following 24 hours (24h-sustained pain relief).
Time frame: 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
headache recurrence
Definition of the moment of possible migraine pain recurrence (headache recurrence), as well as its intensity within 24 and 48 hours following the administration of the medication (limited to patients who experienced pain freedom within 2 hours).
Time frame: 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
use of rescue medication
Use of rescue medications and evaluation of the time interval between the first and second dose.
Time frame: 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
Variation of Migraine Specific Quality of Life Questionnaire score at week 24
Changes in scores of the Migraine Specific Quality of Life Questionnaire administered at week 24 compared to baseline
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Variation of Migraine Specific Quality of Life Questionnaire score at week 24
Changes in scores of the Migraine Specific Quality of Life Questionnaire administered at week 24 compared to week 12
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Variation of Migraine Interictal Burden Scale score at week 24
Changes in scores of the Migraine Specific Quality of Life Questionnaire administered at week 24 compared to baseline
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Variation of Migraine Interictal Burden Scale score at week 24
Changes in score of the Migraine Interictal Burden Scale administered at week 24 compared to week 12
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Variation of Headache Impact Test score at week 24
Changes in score of Headache Impact Test scale administered at week 24 compared to baseline
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Variation of Headache Impact Test score score at week 24
Changes in score of Headache Impact Test scale administered at week 24 compared to week 12
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Patient Global Impression of Change
Collection of subjective feedback from the patient regarding their experience with the medication, assessing patient satisfaction, ease of use of the medication, and perceived effectiveness with Patient Global Impression of Change scale
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Adverse events occurrence
Definition of the type and number of adverse events occurring within 48 hours of taking the combination of sumatriptan 85 mg and naproxen 500 mg through a specific questionnaire (event details, duration, severity, and actions taken).
Time frame: 48 hours after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.