Migraine, Without Aura
Conditions
Keywords
sumatriptan succinate,, naproxen sodium,, parallel group,, double-blind,, placebo-controlled,, Combination product,, migrainous headache, Probable migraine, a sub-type of Migraine, probable migraine,
Brief summary
This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
Interventions
DRUGsumatriptan succinate / naproxen sodium
sumatriptan 85mg / naproxen sodium 500mg
DRUGPlacebo
Placebo to match Treximet tablets
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* At least a 6 month history of probably migraine (6 migraine attacks per month) * Males and women of childbearing potential on a adequate contraception.
Exclusion criteria
* Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use * Pregnant and/or nursing mother * History of cardiovascular disease. * Uncontrolled hypertension. * Basilar or Hemiplegic migraine * History of stroke or transient ischemic attacks (TIA). * History of epilepsy or treated with anti-epileptics within the past 5 years. * Impaired hepatic or renal function. * History of gastrointestinal bleeding or ulceration. * Allergy or hypersensitivity to Aspirin or any other NSAID. * Allergy or hypersensitivity to triptans. * Participated in an investigational drug trial in the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | 2 hours through 24 hours after Treatment | Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Headache Relief 2-24 Hours After Treatment | 2-24 hours after treatment | Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication. |
| Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | 0.5, 1, 2, and 4 hours after treatment | Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time. |
| Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment | 0 - 24 hours after treatment | Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack. |
| Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | 0.5, 1, and 4 hours after Treatment | Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment. |
| Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | 1-2 and 2-4 hours after treatment | Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.) |
| Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | 2 and 4 hours after treatment | Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.) |
| Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | 0 - 24 hours after treatment | Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction. |
| Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment | 1-2, and 2- 4 hours after treatment | Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Baseline Characteristics used the Safety Population. Not the Randomised Population | 246 |
| Sumatriptan/Naproxen Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population | 254 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 23 | 23 |
| Overall Study | No opportunity to treat headache | 32 | 34 |
| Overall Study | Not eligible | 6 | 7 |
| Overall Study | Not otherwise specified | 11 | 7 |
| Overall Study | Protocol Violation | 2 | 12 |
| Overall Study | Sponsor terminated Study | 0 | 1 |
| Overall Study | Withdrawal by Subject | 15 | 18 |
Baseline characteristics
| Characteristic | Sumatriptan/Naproxen | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 35.8 years STANDARD_DEVIATION 11.47 | 36.6 years STANDARD_DEVIATION 11.23 | 36.2 years STANDARD_DEVIATION 11.35 |
| Gender Female | 195 Participants | 176 Participants | 371 Participants |
| Gender Male | 59 Participants | 70 Participants | 129 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 30 Participants | 28 Participants | 58 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 8 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 5 Participants | 8 Participants | 13 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed race | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 206 Participants | 199 Participants | 405 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 246 | 0 / 254 |
| serious Total, serious adverse events | 0 / 246 | 0 / 254 |
Outcome results
Primary
Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.
Time frame: 2 hours through 24 hours after Treatment
Population: The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Pain-Free (2 hours) | 25 Participants |
| Placebo | Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Sustained Pain-Free (2-24 hours) | 20 Participants |
| Sumatriptan/Naproxen | Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Pain-Free (2 hours) | 64 Participants |
| Sumatriptan/Naproxen | Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. | Sustained Pain-Free (2-24 hours) | 54 Participants |
Comparison: Pain-Free (2 hours)p-value: <0.00195% CI: [10, 25]Cochran-Mantel-Haenszel
Comparison: Sustained Pain-Free (2-24 hours)p-value: <0.00195% CI: [8, 22]Cochran-Mantel-Haenszel
Secondary
Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment
Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.
Time frame: 0.5, 1, and 4 hours after Treatment
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Pain-free at 4 hours | 60 Participants |
| Placebo | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Pain-free at 1 hour | 16 Participants |
| Placebo | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Pain-free at 0.5 hour | 6 Participants |
| Sumatriptan/Naproxen | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Pain-free at 4 hours | 105 Participants |
| Sumatriptan/Naproxen | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Pain-free at 1 hour | 23 Participants |
| Sumatriptan/Naproxen | Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment | Pain-free at 0.5 hour | 5 Participants |
Secondary
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment
Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.
Time frame: 0.5, 1, 2, and 4 hours after treatment
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Headache relief at 4 hours | 108 Participants |
| Placebo | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Headache relief at 2 hours | 113 Participants |
| Placebo | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Headache relief at 1 hour | 73 Participants |
| Placebo | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Headache relief at 0.5 hour | 39 Participants |
| Sumatriptan/Naproxen | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Headache relief at 0.5 hour | 41 Participants |
| Sumatriptan/Naproxen | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Headache relief at 4 hours | 153 Participants |
| Sumatriptan/Naproxen | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Headache relief at 1 hour | 85 Participants |
| Sumatriptan/Naproxen | Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment | Headache relief at 2 hours | 124 Participants |
Secondary
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment
Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)
Time frame: 2 and 4 hours after treatment
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Photophobia at 4 hours | 87 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Sinus Pain at 4 hours | 88 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Phonophobia at 4 hours | 83 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Neck Pain at 4 hours | 93 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Phonophobia at 2 hours | 53 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Photophobia at 2 hours | 60 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Nausea at 4 hours | 82 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Neck Pain at 2 hours | 68 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Nausea at 2 hours | 37 Participants |
| Placebo | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Sinus Pain at 2 hours | 49 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Nausea at 2 hours | 36 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Sinus Pain at 2 hours | 36 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Photophobia at 4 hours | 60 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Photophobia at 2 hours | 46 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Neck Pain at 4 hours | 63 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Neck Pain at 2 hours | 59 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Sinus Pain at 4 hours | 49 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Phonophobia at 4 hours | 59 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Phonophobia at 2 hours | 54 Participants |
| Sumatriptan/Naproxen | Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment | Headache-Assoc. Nausea at 4 hours | 51 Participants |
Secondary
Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours
Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)
Time frame: 1-2 and 2-4 hours after treatment
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | Intermed. Sustained Pain-free, 2-4 hrs post-dose | 22 Participants |
| Placebo | Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | Intermed. Sustained Pain-free, 1-2 hrs post-dose | 11 Participants |
| Sumatriptan/Naproxen | Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | Intermed. Sustained Pain-free, 2-4 hrs post-dose | 61 Participants |
| Sumatriptan/Naproxen | Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours | Intermed. Sustained Pain-free, 1-2 hrs post-dose | 23 Participants |
Secondary
Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment
Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)
Time frame: 1-2, and 2- 4 hours after treatment
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment | Intermed. Sustained Pain Relief, 2-4 hrs post-dose | 92 Participants |
| Placebo | Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment | Intermed. Sustained Pain Relief, 1-2 hrs post-dose | 67 Participants |
| Sumatriptan/Naproxen | Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment | Intermed. Sustained Pain Relief, 2-4 hrs post-dose | 118 Participants |
| Sumatriptan/Naproxen | Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment | Intermed. Sustained Pain Relief, 1-2 hrs post-dose | 84 Participants |
Secondary
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score
Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.
Time frame: 0 - 24 hours after treatment
Population: ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Ease-of-Use Adjusted Mean | 84 Score in scale | Standard Error 1.3 |
| Placebo | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Functionality Adjusted Mean | 56 Score in scale | Standard Error 2.1 |
| Placebo | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Bothersome-of-Side Effects Adjusted Mean | 94 Score in scale | Standard Error 0.8 |
| Placebo | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Total Score adjusted Mean | 64 Score in scale | Standard Error 1.5 |
| Placebo | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Efficacy Adjusted Mean | 53 Score in scale | Standard Error 2 |
| Sumatriptan/Naproxen | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Total Score adjusted Mean | 75 Score in scale | Standard Error 1.6 |
| Sumatriptan/Naproxen | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Efficacy Adjusted Mean | 67 Score in scale | Standard Error 2 |
| Sumatriptan/Naproxen | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Functionality Adjusted Mean | 70 Score in scale | Standard Error 2.1 |
| Sumatriptan/Naproxen | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Ease-of-Use Adjusted Mean | 88 Score in scale | Standard Error 1.3 |
| Sumatriptan/Naproxen | Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score | Bothersome-of-Side Effects Adjusted Mean | 91 Score in scale | Standard Error 0.8 |
Secondary
Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment
Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.
Time frame: 0 - 24 hours after treatment
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment | 101 Participants |
| Sumatriptan/Naproxen | Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment | 61 Participants |
Secondary
Sustained Headache Relief 2-24 Hours After Treatment
Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.
Time frame: 2-24 hours after treatment
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Sustained Headache Relief 2-24 Hours After Treatment | 77 Participants |
| Sumatriptan/Naproxen | Sustained Headache Relief 2-24 Hours After Treatment | 110 Participants |