Migraine Disorders
Conditions
Keywords
Migraine with or without aura, Migraine efficacy, Migraine, Migraine headache, Adolescent migraine, TREXIMET, Sumatriptan succinate, Naproxen sodium, Migraine, acute
Brief summary
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old
Detailed description
The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a \ 25 week period.
Interventions
Sumatriptan succinate and naproxen sodium
DRUGPlacebo
Placebo to match
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Subjects eligible for enrollment in the study must meet all of the following criteria: 1. Subject is \>/=12 years of age and \</=17 years of age at the Screening Visit. 2. Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least two, but no more than eight attacks per month, for the six months prior to the Screening Visit is required. Attacks should last a minimum of three hours and be associated with moderate-to-severe headache pain. 3. Subject is able to distinguish migraine from other headaches (i.e., tension-type headaches). 4. Male or female subjects. Female subjects are eligible for participation in the study if they are: 1. Females of non-childbearing potential; or 2. Females of childbearing potential, and who have a negative urine pregnancy test at screening, and agree to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy 5. Any subject taking oral contraceptives at enrollment must be on a stable regimen for at least 2 months prior to screening. 6. Subject and subject's parent or legal guardian are able to read and write English or Spanish. 7. Subject is able to read, comprehend, and complete subject diaries. 8. Subject's parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study. 9. Subject is willing and able to provide Informed Assent prior to entry into the study (if required). \-
Exclusion criteria
* Subjects meeting any of the following criteria must not be enrolled in the study: 1. Subject is \< 74 pounds (33.3 kg). 2. Subject has ≥15 headache days per month in total (migraine, probable migraine, or tension-type), retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic migraine (ICHD-II 1.2.4), or secondary headaches. 3. Subject, in the investigator's opinion is likely to have unrecognized cardiovascular or cerebrovascular disease. 4. Subject has uncontrolled hypertension at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker. 5. Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study. 6. Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs/symptoms consistent with any of the above. 7. Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening. 8. Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study. 9. Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma. 10. Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized. 11. Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months. 12. Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the two weeks prior to screening through two weeks post treatment. 13. Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent. 14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease. 15. Subject is pregnant, actively trying to become pregnant, or breast feeding or subject is not willing to have pregnancy test(s). 16. Subject tests positive for illicit substances on toxicology screen, or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial. 17. Subject has participated in any investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Pain Free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Phonophobia-free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed. |
| Number of Participants Sustained Photophobia-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication. |
| Number of Participants Sustained Phonophobia-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication. |
| Number of Participants Sustained Nausea-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication. |
| Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive. |
| Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued \< 2 hours post-treatment. |
| Number of Participants Nausea-free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | The number of participants who did not have nausea at 2 hours post dose was analzyed. |
| Number of Participants Sustained Pain-free From 2-24 Hours | 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13) | Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication. |
| Number of Participants Photophobia-free at 2 Hours Post-dose | 2 hours after single dose of double-blind treatment (Randomization through Week 13) | The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed. |
| Number of Participants Pain-free at 1 Hour Post-dose | 1 hour after single dose of double-blind treatment (Randomization through Week 13) | Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Female and Male Participants Categorized by Age Group | Baseline | The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups. |
| Number of Participants of the Indicated Race Categorized by Age Group | Baseline | The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups. |
| Mean Weight of Participants at Baseline Categorized by Age Group | Baseline | The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. |
| Mean Body Mass Index of Participants at Baseline Categorized by Age Group | Baseline | The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms \[kg\]) divided by height (meters \[m\]\^2). |
| Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | Baseline | The number of participants receiving double-blind treatment were reported according to age. |
| Mean Age of Participants at Baseline Categorized by Age Group | Baseline | The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo A single matching placebo tablet taken within a 12-week period | 145 |
| Sumatriptan 10 mg/ Naproxen 60 mg A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period | 96 |
| Sumatriptan 30 mg/ Naproxen 180 mg A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period | 97 |
| Sumatriptan 85 mg/ Naproxen 500 mg A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period | 152 |
| Total | 490 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Double-blind Treatment Phase | Adverse Event | 0 | 0 | 0 | 0 | 1 | 1 |
| Double-blind Treatment Phase | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 | 0 |
| Double-blind Treatment Phase | Lost to Follow-up | 0 | 0 | 8 | 4 | 4 | 4 |
| Double-blind Treatment Phase | No opportunity to treat migraine | 0 | 0 | 20 | 10 | 13 | 14 |
| Double-blind Treatment Phase | Physician Decision | 0 | 0 | 0 | 3 | 1 | 1 |
| Double-blind Treatment Phase | Protocol Violation | 0 | 0 | 3 | 0 | 0 | 3 |
| Double-blind Treatment Phase | Withdrawal by Subject | 0 | 0 | 0 | 6 | 0 | 2 |
| Single-blind Placebo Run-In Phase | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 |
| Single-blind Placebo Run-In Phase | Did not meet continuation criteria | 79 | 74 | 0 | 0 | 0 | 0 |
| Single-blind Placebo Run-In Phase | Lost to Follow-up | 36 | 31 | 0 | 0 | 0 | 0 |
| Single-blind Placebo Run-In Phase | Other | 0 | 1 | 0 | 0 | 0 | 0 |
| Single-blind Placebo Run-In Phase | Physician Decision | 2 | 6 | 0 | 0 | 0 | 0 |
| Single-blind Placebo Run-In Phase | Protocol Violation | 4 | 5 | 0 | 0 | 0 | 0 |
| Single-blind Placebo Run-In Phase | Withdrawal by Subject | 19 | 18 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo | Sumatriptan 10 mg/ Naproxen 60 mg | Sumatriptan 30 mg/ Naproxen 180 mg | Sumatriptan 85 mg/ Naproxen 500 mg |
|---|---|---|---|---|---|
| Age, Continuous | 14.7 Years STANDARD_DEVIATION 1.72 | 14.7 Years STANDARD_DEVIATION 1.76 | 14.8 Years STANDARD_DEVIATION 1.81 | 14.7 Years STANDARD_DEVIATION 1.65 | 14.8 Years STANDARD_DEVIATION 1.69 |
| Body Mass Index | 23.7 Kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.36 | 23.5 Kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.28 | 23.3 Kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.62 | 22.9 Kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 4.53 | 24.6 Kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.68 |
| Gender Female | 287 Participants | 85 Participants | 52 Participants | 56 Participants | 94 Participants |
| Gender Male | 203 Participants | 60 Participants | 44 Participants | 41 Participants | 58 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 63 participants | 25 participants | 17 participants | 9 participants | 12 participants |
| Race/Ethnicity, Customized African American/African Heritage and White | 6 participants | 2 participants | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native and White | 8 participants | 1 participants | 2 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 1 participants | 0 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Asian and Native Hawaiian/other Pacific Islander | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian and White | 5 participants | 3 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Missing | 2 participants | 2 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian/ other Pacific Islander and White | 2 participants | 1 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 397 participants | 108 participants | 75 participants | 84 participants | 130 participants |
| Weight | 64.6 Kilograms (kg) STANDARD_DEVIATION 17.63 | 63.8 Kilograms (kg) STANDARD_DEVIATION 16.67 | 64.2 Kilograms (kg) STANDARD_DEVIATION 19.29 | 62.8 Kilograms (kg) STANDARD_DEVIATION 14.49 | 66.8 Kilograms (kg) STANDARD_DEVIATION 19.13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 145 | 0 / 96 | 3 / 97 | 4 / 152 | 11 / 683 |
| serious Total, serious adverse events | 0 / 145 | 0 / 96 | 0 / 97 | 0 / 152 | 2 / 683 |
Outcome results
Primary
Number of Participants Who Were Pain Free at 2 Hours Post-dose
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.
Time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population: participants who took a dose of double-blind randomized treatment and provided some assessment of their migraine pain or associated symptoms. Participants were not included in this analysis if their baseline pain was not moderate or severe, or if they had no post-baseline evaluation of pain up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Who Were Pain Free at 2 Hours Post-dose | Total Population, n=142, 96, 97, 150 | 14 participants |
| Placebo | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 15-17 years, n=72, 53, 51, 85 | 4 participants |
| Placebo | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 12-14 years, n=70, 43, 46, 65 | 10 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | Total Population, n=142, 96, 97, 150 | 28 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 15-17 years, n=72, 53, 51, 85 | 10 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 12-14 years, n=70, 43, 46, 65 | 18 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 12-14 years, n=70, 43, 46, 65 | 13 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | Total Population, n=142, 96, 97, 150 | 26 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 15-17 years, n=72, 53, 51, 85 | 13 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | Total Population, n=142, 96, 97, 150 | 36 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 15-17 years, n=72, 53, 51, 85 | 19 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Were Pain Free at 2 Hours Post-dose | 12-14 years, n=70, 43, 46, 65 | 17 participants |
p-value: 0.00395% CI: [0.09, 0.3]Cochran-Mantel-Haenszel
p-value: 0.00395% CI: [0.07, 0.26]Cochran-Mantel-Haenszel
p-value: 0.00395% CI: [0.05, 0.22]Cochran-Mantel-Haenszel
Secondary
Number of Participants Nausea-free at 2 Hours Post-dose
The number of participants who did not have nausea at 2 hours post dose was analzyed.
Time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Nausea-free at 2 Hours Post-dose | Total Population, n=144, 95, 96, 151 | 101 participants |
| Placebo | Number of Participants Nausea-free at 2 Hours Post-dose | 15-17 years, n=73, 52, 50, 86 | 46 participants |
| Placebo | Number of Participants Nausea-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 55 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Nausea-free at 2 Hours Post-dose | Total Population, n=144, 95, 96, 151 | 78 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Nausea-free at 2 Hours Post-dose | 15-17 years, n=73, 52, 50, 86 | 42 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Nausea-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 36 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Nausea-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 38 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Nausea-free at 2 Hours Post-dose | Total Population, n=144, 95, 96, 151 | 74 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Nausea-free at 2 Hours Post-dose | 15-17 years, n=73, 52, 50, 86 | 36 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Nausea-free at 2 Hours Post-dose | Total Population, n=144, 95, 96, 151 | 106 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Nausea-free at 2 Hours Post-dose | 15-17 years, n=73, 52, 50, 86 | 59 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Nausea-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 47 participants |
Secondary
Number of Participants Pain-free at 1 Hour Post-dose
Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.
Time frame: 1 hour after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Pain-free at 1 Hour Post-dose | Total Population, n=142, 96, 97, 150 | 6 participants |
| Placebo | Number of Participants Pain-free at 1 Hour Post-dose | 15-17 years, n=72, 53, 51, 85 | 2 participants |
| Placebo | Number of Participants Pain-free at 1 Hour Post-dose | 12-14 years, n=70, 43, 46, 65 | 4 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Pain-free at 1 Hour Post-dose | Total Population, n=142, 96, 97, 150 | 9 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Pain-free at 1 Hour Post-dose | 15-17 years, n=72, 53, 51, 85 | 2 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Pain-free at 1 Hour Post-dose | 12-14 years, n=70, 43, 46, 65 | 7 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Pain-free at 1 Hour Post-dose | 12-14 years, n=70, 43, 46, 65 | 2 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Pain-free at 1 Hour Post-dose | Total Population, n=142, 96, 97, 150 | 6 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Pain-free at 1 Hour Post-dose | 15-17 years, n=72, 53, 51, 85 | 4 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Pain-free at 1 Hour Post-dose | Total Population, n=142, 96, 97, 150 | 11 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Pain-free at 1 Hour Post-dose | 15-17 years, n=72, 53, 51, 85 | 7 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Pain-free at 1 Hour Post-dose | 12-14 years, n=70, 43, 46, 65 | 4 participants |
Secondary
Number of Participants Phonophobia-free at 2 Hours Post-dose
The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.
Time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Phonophobia-free at 2 Hours Post-dose | Total Population, n=144, 96, 96, 151 | 60 participants |
| Placebo | Number of Participants Phonophobia-free at 2 Hours Post-dose | 15-17 years, n=73, 53, 50, 86 | 26 participants |
| Placebo | Number of Participants Phonophobia-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 34 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | Total Population, n=144, 96, 96, 151 | 59 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | 15-17 years, n=73, 53, 50, 86 | 47 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 32 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 33 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | Total Population, n=144, 96, 96, 151 | 55 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | 15-17 years, n=73, 53, 50, 86 | 22 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | Total Population, n=144, 96, 96, 151 | 90 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | 15-17 years, n=73, 53, 50, 86 | 49 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Phonophobia-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 41 participants |
Secondary
Number of Participants Photophobia-free at 2 Hours Post-dose
The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.
Time frame: 2 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Photophobia-free at 2 Hours Post-dose | Total Population, n=144, 96, 96, 151 | 59 participants |
| Placebo | Number of Participants Photophobia-free at 2 Hours Post-dose | 15-17 years, n=73, 53, 50, 86 | 26 participants |
| Placebo | Number of Participants Photophobia-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 33 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | Total Population, n=144, 96, 96, 151 | 57 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | 15-17 years, n=73, 53, 50, 86 | 28 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 29 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 24 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | Total Population, n=144, 96, 96, 151 | 47 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | 15-17 years, n=73, 53, 50, 86 | 23 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | Total Population, n=144, 96, 96, 151 | 89 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | 15-17 years, n=73, 53, 50, 86 | 48 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Photophobia-free at 2 Hours Post-dose | 12-14 years, n=71, 43, 46, 65 | 41 participants |
Secondary
Number of Participants Sustained Nausea-free From 2-24 Hours
Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.
Time frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Sustained Nausea-free From 2-24 Hours | 15-17 years, n=73, 52, 50, 86 | 29 participants |
| Placebo | Number of Participants Sustained Nausea-free From 2-24 Hours | Total Population, n=144, 95, 96, 151 | 68 participants |
| Placebo | Number of Participants Sustained Nausea-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 39 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 31 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | Total Population, n=144, 95, 96, 151 | 67 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | 15-17 years, n=73, 52, 50, 86 | 36 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 33 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | Total Population, n=144, 95, 96, 151 | 64 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | 15-17 years, n=73, 52, 50, 86 | 31 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | Total Population, n=144, 95, 96, 151 | 94 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | 15-17 years, n=73, 52, 50, 86 | 51 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Nausea-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 43 participants |
Secondary
Number of Participants Sustained Pain-free From 2-24 Hours
Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.
Time frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Sustained Pain-free From 2-24 Hours | Total Population, n=142, 96, 97, 150 | 13 participants |
| Placebo | Number of Participants Sustained Pain-free From 2-24 Hours | 15-17 years, n=72, 53, 51, 85 | 3 participants |
| Placebo | Number of Participants Sustained Pain-free From 2-24 Hours | 12-14 years, n=70, 43, 46, 65 | 10 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Pain-free From 2-24 Hours | Total Population, n=142, 96, 97, 150 | 23 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Pain-free From 2-24 Hours | 15-17 years, n=72, 53, 51, 85 | 9 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Pain-free From 2-24 Hours | 12-14 years, n=70, 43, 46, 65 | 14 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Pain-free From 2-24 Hours | 12-14 years, n=70, 43, 46, 65 | 12 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Pain-free From 2-24 Hours | Total Population, n=142, 96, 97, 150 | 24 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Pain-free From 2-24 Hours | 15-17 years, n=72, 53, 51, 85 | 12 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Pain-free From 2-24 Hours | Total Population, n=142, 96, 97, 150 | 35 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Pain-free From 2-24 Hours | 15-17 years, n=72, 53, 51, 85 | 18 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Pain-free From 2-24 Hours | 12-14 years, n=70, 43, 46, 65 | 17 participants |
Secondary
Number of Participants Sustained Phonophobia-free From 2-24 Hours
Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.
Time frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Sustained Phonophobia-free From 2-24 Hours | Total Population, n=144, 96, 96, 151 | 47 participants |
| Placebo | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 15-17 years, n=73, 53, 50, 86 | 20 participants |
| Placebo | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 27 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | Total Population, n=144, 96, 96, 151 | 48 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 15-17 years, n=73, 53, 50, 86 | 24 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 24 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 31 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | Total Population, n=144, 96, 96, 151 | 51 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 15-17 years, n=73, 53, 50, 86 | 20 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | Total Population, n=144, 96, 96, 151 | 79 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 15-17 years, n=73, 53, 50, 86 | 43 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Phonophobia-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 36 participants |
Secondary
Number of Participants Sustained Photophobia-free From 2-24 Hours
Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.
Time frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Sustained Photophobia-free From 2-24 Hours | Total Population, n=144, 96, 96, 151 | 44 participants |
| Placebo | Number of Participants Sustained Photophobia-free From 2-24 Hours | 15-17 years, n=73, 53, 50, 86 | 19 participants |
| Placebo | Number of Participants Sustained Photophobia-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 25 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | Total Population, n=144, 96, 96, 151 | 48 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | 15-17 years, n=73, 53, 50, 86 | 27 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 21 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 21 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | Total Population, n=144, 96, 96, 151 | 43 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | 15-17 years, n=73, 53, 50, 86 | 22 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | Total Population, n=144, 96, 96, 151 | 75 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | 15-17 years, n=73, 53, 50, 86 | 40 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Sustained Photophobia-free From 2-24 Hours | 12-14 years, n=71, 43, 46, 65 | 35 participants |
Secondary
Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.
Time frame: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | Total Population, n=145, 96, 97, 152 | 47 participants |
| Placebo | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 15-17 years, n=74, 53, 51, 87 | 26 participants |
| Placebo | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 12-14 years, n=71, 43, 46, 65 | 21 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | Total Population, n=145, 96, 97, 152 | 14 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 15-17 years, n=74, 53, 51, 87 | 9 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 12-14 years, n=71, 43, 46, 65 | 5 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 12-14 years, n=71, 43, 46, 65 | 6 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | Total Population, n=145, 96, 97, 152 | 16 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 15-17 years, n=74, 53, 51, 87 | 10 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | Total Population, n=145, 96, 97, 152 | 21 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 15-17 years, n=74, 53, 51, 87 | 11 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose | 12-14 years, n=71, 43, 46, 65 | 10 participants |
Secondary
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued \< 2 hours post-treatment.
Time frame: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Population: ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 18 hours, n=145, 96, 96, 152 | 50 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 2 hours, n=145, 96, 96, 152 | 10 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 3 hours, n=145, 96, 96, 152 | 29 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 4 hours, n=145, 96, 96, 152 | 34 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 8 hours, n=145, 96, 96, 152 | 45 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 12 hours, n=145, 96, 96, 152 | 48 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 1 hour, n=145, 96, 96, 152 | 2 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 24 hours, n=145, 96, 96, 152 | 52 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 1 hour, n=71, 43, 46, 65 | 1 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 2 hours, n=71, 43, 46, 65 | 4 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 3 hours, n=71, 43, 46, 65 | 11 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 4 hours, n=71, 43, 46, 65 | 14 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 8 hours, n=71, 43, 46, 65 | 20 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 12 hours, n=71, 43, 46, 65 | 10 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 18 hours, n=71, 43, 46, 65 | 21 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 24 hours, n=71, 43, 46, 65 | 22 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 1 hour, n=74, 53, 50, 87 | 1 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 2 hours, n=74, 53, 50, 87 | 6 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 3 hours, n=74, 53, 50, 87 | 18 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 4 hours, n=74, 53, 50, 87 | 20 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 8 hours, n=74, 53, 50, 87 | 25 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 12 hours, n=74, 53, 50, 87 | 28 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 18 hours, n=74, 53, 50, 87 | 29 participants |
| Placebo | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 24 hours, n=74, 53, 50, 87 | 30 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 24 hours, n=74, 53, 50, 87 | 9 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 8 hours, n=71, 43, 46, 65 | 4 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 4 hours, n=145, 96, 96, 152 | 6 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 18 hours, n=74, 53, 50, 87 | 9 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 12 hours, n=74, 53, 50, 87 | 7 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 12 hours, n=71, 43, 46, 65 | 4 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 1 hour, n=71, 43, 46, 65 | 0 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 1 hour, n=74, 53, 50, 87 | 0 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 12 hours, n=145, 96, 96, 152 | 11 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 18 hours, n=71, 43, 46, 65 | 4 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 3 hours, n=145, 96, 96, 152 | 6 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 24 hours, n=71, 43, 46, 65 | 5 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 8 hours, n=74, 53, 50, 87 | 5 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 2 hours, n=71, 43, 46, 65 | 0 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 4 hours, n=74, 53, 50, 87 | 5 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 2 hours, n=145, 96, 96, 152 | 0 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 24 hours, n=145, 96, 96, 152 | 14 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 3 hours, n=71, 43, 46, 65 | 1 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 18 hours, n=145, 96, 96, 152 | 13 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 3 hours, n=74, 53, 50, 87 | 5 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 1 hour, n=145, 96, 96, 152 | 0 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 4 hours, n=71, 43, 46, 65 | 1 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 8 hours, n=145, 96, 96, 152 | 9 participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 2 hours, n=74, 53, 50, 87 | 0 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 3 hours, n=71, 43, 46, 65 | 2 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 18 hours, n=145, 96, 96, 152 | 15 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 24 hours, n=145, 96, 96, 152 | 17 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 1 hour, n=71, 43, 46, 65 | 0 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 2 hours, n=71, 43, 46, 65 | 1 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 8 hours, n=74, 53, 50, 87 | 11 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 4 hours, n=74, 53, 50, 87 | 9 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 4 hours, n=71, 43, 46, 65 | 4 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 8 hours, n=71, 43, 46, 65 | 4 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 12 hours, n=71, 43, 46, 65 | 4 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 12 hours, n=74, 53, 50, 87 | 11 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 18 hours, n=71, 43, 46, 65 | 4 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 24 hours, n=71, 43, 46, 65 | 6 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 24 hours, n=74, 53, 50, 87 | 11 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 1 hour, n=74, 53, 50, 87 | 0 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 2 hours, n=74, 53, 50, 87 | 5 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 18 hours, n=74, 53, 50, 87 | 11 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 1 hour, n=145, 96, 96, 152 | 0 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 2 hours, n=145, 96, 96, 152 | 6 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 3 hours, n=74, 53, 50, 87 | 9 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 3 hours, n=145, 96, 96, 152 | 11 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 4 hours, n=145, 96, 96, 152 | 13 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 8 hours, n=145, 96, 96, 152 | 15 participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 12 hours, n=145, 96, 96, 152 | 15 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 18 hours, n=74, 53, 50, 87 | 12 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 8 hours, n=74, 53, 50, 87 | 10 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 24 hours, n=145, 96, 96, 152 | 23 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 1 hour, n=145, 96, 96, 152 | 2 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 3 hours, n=71, 43, 46, 65 | 7 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 2 hours, n=71, 43, 46, 65 | 1 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 12 hours, n=145, 96, 96, 152 | 20 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 2 hours, n=145, 96, 96, 152 | 3 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 8 hours, n=145, 96, 96, 152 | 20 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 1 hour, n=71, 43, 46, 65 | 0 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 4 hours, n=74, 53, 50, 87 | 8 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 3 hours, n=145, 96, 96, 152 | 15 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 12 hours, n=74, 53, 50, 87 | 10 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 18 hours, n=71, 43, 46, 65 | 10 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 3 hours, n=74, 53, 50, 87 | 8 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 24 hours, n=71, 43, 46, 65 | 10 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 24 hours, n=74, 53, 50, 87 | 13 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 12 hours, n=71, 43, 46, 65 | 10 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 18 hours, n=145, 96, 96, 152 | 22 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 1 hour, n=74, 53, 50, 87 | 2 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 8 hours, n=71, 43, 46, 65 | 10 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 12-14 years, 4 hours, n=71, 43, 46, 65 | 8 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | Total Population, 4 hours, n=145, 96, 96, 152 | 16 participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points | 15-17 years, 2 hours, n=74, 53, 50, 87 | 2 participants |
Other Pre-specified
Mean Age of Participants at Baseline Categorized by Age Group
The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.
Time frame: Baseline
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Age of Participants at Baseline Categorized by Age Group | 13.1 Years | Standard Deviation 0.79 |
| Sumatriptan 10 mg/ Naproxen 60 mg | Mean Age of Participants at Baseline Categorized by Age Group | 16.1 Years | Standard Deviation 0.84 |
Other Pre-specified
Mean Body Mass Index of Participants at Baseline Categorized by Age Group
The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms \[kg\]) divided by height (meters \[m\]\^2).
Time frame: Baseline
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Body Mass Index of Participants at Baseline Categorized by Age Group | 22.6 Kilograms per meters squared (kg/m^2) | Standard Deviation 5.06 |
| Sumatriptan 10 mg/ Naproxen 60 mg | Mean Body Mass Index of Participants at Baseline Categorized by Age Group | 24.6 Kilograms per meters squared (kg/m^2) | Standard Deviation 5.44 |
Other Pre-specified
Mean Weight of Participants at Baseline Categorized by Age Group
The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.
Time frame: Baseline
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Weight of Participants at Baseline Categorized by Age Group | 58.7 Kilograms (kg) | Standard Deviation 15.55 |
| Sumatriptan 10 mg/ Naproxen 60 mg | Mean Weight of Participants at Baseline Categorized by Age Group | 69.6 Kilograms (kg) | Standard Deviation 17.78 |
Other Pre-specified
Number of Female and Male Participants Categorized by Age Group
The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Time frame: Baseline
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Female and Male Participants Categorized by Age Group | Female | 114 Participants |
| Placebo | Number of Female and Male Participants Categorized by Age Group | Male | 111 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Female and Male Participants Categorized by Age Group | Female | 173 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Female and Male Participants Categorized by Age Group | Male | 92 Participants |
Other Pre-specified
Number of Participants of the Indicated Race Categorized by Age Group
The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Time frame: Baseline
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | Native Hawaiian or other Pacific Islander | 1 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | American Indian or Alaska Native and White | 4 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | Asian | 2 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | Asian and Native Hawaiian/other Pacific Islander | 0 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | White | 181 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | Asian and White | 2 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | American Indian or Alaska Native | 1 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | Native Hawaiian/ other Pacific Islander and White | 0 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | African American/African Heritage and White | 2 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | Missing | 1 Participants |
| Placebo | Number of Participants of the Indicated Race Categorized by Age Group | African American/African Heritage | 31 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | Missing | 1 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | African American/African Heritage | 32 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | American Indian or Alaska Native | 0 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | Asian | 2 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | Native Hawaiian or other Pacific Islander | 0 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | White | 216 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | African American/African Heritage and White | 4 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | American Indian or Alaska Native and White | 4 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | Asian and Native Hawaiian/other Pacific Islander | 1 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | Asian and White | 3 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants of the Indicated Race Categorized by Age Group | Native Hawaiian/ other Pacific Islander and White | 2 Participants |
Other Pre-specified
Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
The number of participants receiving double-blind treatment were reported according to age.
Time frame: Baseline
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | 12-14 years | 71 Participants |
| Placebo | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | 15-17 years | 74 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | 15-17 years | 53 Participants |
| Sumatriptan 10 mg/ Naproxen 60 mg | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | 12-14 years | 43 Participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | 12-14 years | 46 Participants |
| Sumatriptan 30 mg/ Naproxen 180 mg | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | 15-17 years | 51 Participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | 12-14 years | 65 Participants |
| Sumatriptan 85 mg/ Naproxen 500 mg | Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline | 15-17 years | 87 Participants |