Trial · NCT06868953
Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study
NCT06868953, Not yet recruiting, IRCCS San Raffaele Roma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study. Trials, record NCT06868953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06868953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study
- NCT number
- NCT06868953
- Status
- Not yet recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- IRCCS San Raffaele Roma
- Conditions
- Migraine
- Interventions
- combination of sumatriptan 85 mg and naproxen 500 mg
- First posted
- 2025-03-11
- Last updated
- 2025-03-11
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2 hour-pain freedom | 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). |
| Secondary | 1 hour-pain freedom | 1 hour after taking combination of sumatriptan 85 mg and naproxen 500 mg | 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). |
| Secondary | 2 hour-pain relief | 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | 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) |
| Secondary | Disappearence of Most Bothersome Symptom | 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | 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. |
| Secondary | Presence or absence of associated symptoms (nausea, vomiting, photophobia, or phonophobia) | 1-48 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | 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. |
| Secondary | 24 hour-sustained pain freedom | 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | 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). |
| Secondary | 24 hour sustained pain relief | 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | 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). |
| Secondary | headache recurrence | 2 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | 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). |
| Secondary | use of rescue medication | 24 hours after taking combination of sumatriptan 85 mg and naproxen 500 mg | Use of rescue medications and evaluation of the time interval between the first and second dose. |
| Secondary | Variation of Migraine Specific Quality of Life Questionnaire score at week 24 | week 24 after taking the first dose of combination of sumatriptan 85 mg and naproxen 500 mg | Changes in scores of the Migraine Specific Quality of Life Questionnaire administered at week 24 compared to baseline |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06868953
GET https://conductscience.org/api/trials/v1/NCT06868953/registered