A Phase 4 interventional study of Sumatriptan 100 mg and Naproxen in Migraine, Tension-type Headache and Primary Headache Disorder, sponsored by Montefiore Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department (ED) treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for the treatment of recurrent headache within 24 hours of emergency department discharge.
Two-thirds of the five million headache patients who present to US emergency departments (ED) annually are suffering an acute exacerbation of a primary headache disorder. Of these acute primary headaches, migraine is the most frequently encountered disease entity in the ED, accounting for 60% of primary headaches, followed by tension-type headaches, which represent 10% of all primary headaches seen in the ED. About ¼ of all acute primary headaches seen in the ED cannot readily be given a specific diagnosis3. Multiple parenteral treatments are used to treat acute primary headaches1, but to date, regardless of specific headache diagnosis, no medication eliminates the frequent recurrence of headache after ED discharge. To date, it is unknown which medication patients should be given when discharged from an ED after treatment for a primary headache. This study will compare two oral headache treatments to determine which one relives pain more effectively.
Specific aims:
Primary hypotheses:
In the 48 hour period following ED treatment for a primary headache, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 401 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sumatriptan 100 mg tablet
Drug: Sumatriptan 100 mg
Naproxen 500 mg tablet
Drug: Naproxen
Sumatriptan 100mg tablet
Naproxen 500mg tablet
Numerical Rating Scale
Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable. Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief
Time frame: Baseline, two hours
Headache-related Functional Disability
This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment.
Time frame: Baseline, two hours
Patient Satisfaction
At the 48 hour assessment, patients were asked, "The next time you go to an emergency room with a headache, do you want to receive the same medication". This outcome tabulates the number of affirmative responses.
Time frame: 48 hours after ER discharge
| Milestone | Sumatriptan | Naproxen |
|---|---|---|
| Started | 203 | 198 |
| Completed | 98 | 98 |
| Not completed | 105 | 100 |
| Withdrew: Lost to follow-up | 10 | 8 |
| Withdrew: Did not require medication | 95 | 92 |
Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable. Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief
| units on a scale | Sumatriptan | Naproxen |
|---|---|---|
| Numerical Rating Scale | 4.1 ± 3.1 | 4.3 ± 3.0 |
This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment.
| participants | Sumatriptan | Naproxen |
|---|---|---|
| Headache-related Functional Disability | 41 | 36 |
At the 48 hour assessment, patients were asked, "The next time you go to an emergency room with a headache, do you want to receive the same medication". This outcome tabulates the number of affirmative responses.
| participants | Sumatriptan | Naproxen |
|---|---|---|
| Patient Satisfaction | 69 | 68 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sumatriptan | — | 0/98 (0%) | 25/97 (25.8%) |
| Naproxen | — | 0/98 (0%) | 18/97 (18.6%) |
| Event | Sumatriptan | Naproxen |
|---|---|---|
| OtherMusculoskeletal and connective tissue disorders | 12/97 | 0/97 |
| NeurologicalNervous system disorders | 4/97 | 11/97 |
| Gastrointestinal complaintGastrointestinal disorders | 9/97 | 7/97 |
| Age, Continuous(years) | Sumatriptan | Naproxen | Total |
|---|---|---|---|
| Mean | 36 ± 10 | 35 ± 10 | 36 ± 10 |
| Sex: Female, Male(Participants) | Sumatriptan | Naproxen | Total |
|---|---|---|---|
| Female | 173 | 168 | 341 |
| Male | 30 | 30 | 60 |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Sumatriptan · Naproxen