NCT06868953Not yet recruiting
Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- 10 Apr 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- IRCCS San Raffaele Roma
- Diseases
- Migraine
- NCT number
- NCT06868953
What you commit to
- Study type: Observational
- Planned participants: 300
- From 10 Apr 2025 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Headache with the use of acute medication on more than 10 days per month in each of the 3 months prior to screening
Lab values
- Comorbidities with other neurological, cardiovascular, hepatic, respiratory, hematological, or autoimmune diseases, or clinically significant laboratory abnormalities
Age
- Age \<18 years or \>65 years
Other
- Pregnancy or breastfeeding
- Poor knowledge of the Italian language
- Inability to distinguish migraine attacks from tension-type headaches
- Migraine characterized by mild attacks or attacks that resolve spontaneously within 2 hours
- Hemiplegic or basilar migraine
- Unwillingness to participate in the study -
Who the study is looking for
- 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 in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.