MigraineSMARTNCT06868953
Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study
An observational study of Migraine, run by IRCCS San Raffaele Roma.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- combination of sumatriptan 85 mg and naproxen 500 mg
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
- Inability to distinguish migraine attacks from tension-type headaches
- Migraine characterized by mild attacks or attacks that resolve spontaneously within 2 hours
Show all 9Show fewer
- Hemiplegic or basilar migraine
- Headache with the use of acute medication on more than 10 days per month in each of the 3 months prior to screening
- Unwillingness to participate in the study -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Migraine
- Being tested
- combination of sumatriptan 85 mg and naproxen 500 mg
- Keywords
- migraine attack
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of sumatriptan 85 mg and naproxen 500 mgDrug
combination of sumatriptan 85 mg and naproxen 500 mg
| Study group | Role | What they receive |
|---|---|---|
| Migraineurs with >4 monthly migraine days | 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. Receives: Drug: combination of sumatriptan 85 mg and naproxen 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
Secondary outcomes (16)
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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 48 hours after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start10 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868953
- Sponsor's protocol ID
- IRCCSSanRaffaeleRoma
- Acronym
- SMART
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith TR, Sunshine A, Stark SR, Littlefield DE, Spruill SE, Alexander WJ. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2005 Sep;45(8):983-91. doi: 10.1111/j.1526-4610.2005.05178.x.
PubMed 16109111Wilcha RJ, Afridi SK, Barbanti P, Diener HC, Jurgens TP, Lanteri-Minet M, Lucas C, Mawet J, Moisset X, Russo A, Sacco S, Sinclair AJ, Sumelahti ML, Tassorelli C, Goadsby PJ. Sumatriptan-naproxen sodium in migraine: A review. Eur J Neurol. 2024 Sep;31 Suppl 2(Suppl 2):e16434. doi: 10.1111/ene.16434.
PubMed 39318200Lipton RB, Dodick DW, Adelman JU, Kaniecki RG, Lener SE, White JD, Nelsen AC. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study. Cephalalgia. 2009 Aug;29(8):826-36. doi: 10.1111/j.1468-2982.2008.01806.x. Epub 2009 Feb 12.
PubMed 19220307Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.
PubMed 17405970Allais G, Castagnoli Gabellari I, Rolando S, Benedetto C. Evaluation of the use of sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea. Expert Rev Neurother. 2011 Oct;11(10):1383-7. doi: 10.1586/ern.11.123.
PubMed 21955195Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.
PubMed 19486178Silberstein S, McDonald SA, Goldstein J, Aurora S, Lener SE, White J, Runken MC, Saiers J, Derosier F, Lipton RB. Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura: a randomized study. Cephalalgia. 2014 Apr;34(4):268-79. doi: 10.1177/0333102413508242. Epub 2013 Oct 9.
PubMed 24108307
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study
- ClinicalTrials.gov ID
- NCT06868953
- Acronym / sponsor ID
- SMART / IRCCSSanRaffaeleRoma
- Conditions
- Migraine
- Keywords
- migraine attack
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraineurs with >4 monthly migraine days | – | Drug: combination of sumatriptan 85 mg and naproxen 500 mgConsecutive 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
- Inability to distinguish migraine attacks from tension-type headaches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of sumatriptan 85 mg and naproxen 500 mgcombination of sumatriptan 85 mg and naproxen 500 mg | Drug | Migraineurs with >4 monthly migraine days |
Primary outcome
2 hour-pain freedom
Time frame: 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
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).
16 secondary outcomes
1 hour-pain freedom
Time frame: 1 hour after taking combination of sumatriptan 85 mg and naproxen 500 mg
2 hour-pain relief
Time frame: 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
Disappearence of Most Bothersome Symptom
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)
Time frame: 1-48 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
24 hour-sustained pain freedom
Time frame: 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
24 hour sustained pain relief
Time frame: 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
headache recurrence
Time frame: 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg
use of rescue medication
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
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
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
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
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
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
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Patient Global Impression of Change
Time frame: week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Adverse events occurrence
Time frame: 48 hours after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 16109111Smith TR, Sunshine A, Stark SR, Littlefield DE, Spruill SE, Alexander WJ. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2005 Sep;45(8):983-91. doi: 10.1111/j.1526-4610.2005.05178.x.
- Background: PubMed 39318200Wilcha RJ, Afridi SK, Barbanti P, Diener HC, Jurgens TP, Lanteri-Minet M, Lucas C, Mawet J, Moisset X, Russo A, Sacco S, Sinclair AJ, Sumelahti ML, Tassorelli C, Goadsby PJ. Sumatriptan-naproxen sodium in migraine: A review. Eur J Neurol. 2024 Sep;31 Suppl 2(Suppl 2):e16434. doi: 10.1111/ene.16434.
- Background: PubMed 19220307Lipton RB, Dodick DW, Adelman JU, Kaniecki RG, Lener SE, White JD, Nelsen AC. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study. Cephalalgia. 2009 Aug;29(8):826-36. doi: 10.1111/j.1468-2982.2008.01806.x. Epub 2009 Feb 12.
- Results publication: PubMed 17405970Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.
- Results publication: PubMed 21955195Allais G, Castagnoli Gabellari I, Rolando S, Benedetto C. Evaluation of the use of sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea. Expert Rev Neurother. 2011 Oct;11(10):1383-7. doi: 10.1586/ern.11.123.
- Results publication: PubMed 19486178Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.
- Results publication: PubMed 24108307Silberstein S, McDonald SA, Goldstein J, Aurora S, Lener SE, White J, Runken MC, Saiers J, Derosier F, Lipton RB. Sumatriptan/naproxen sodium for the acute treatment of probable migraine without aura: a randomized study. Cephalalgia. 2014 Apr;34(4):268-79. doi: 10.1177/0333102413508242. Epub 2013 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by IRCCS San Raffaele Roma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piero Barbanti, MD, PhD (+393357071457, piero.barbanti@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 hour-pain freedom (time frame: 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06868953, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.