Migraine Disorders
Conditions
Keywords
Long-term Safety, Migraine, Adolescent Migraine Headache, sumatriptan succinate, naproxen sodium
Brief summary
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.
Detailed description
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine.
Interventions
DRUGCombination Tablet of Treximet (sumatriptan/naproxen sodium)
Combination Tablet of Treximet(sumatriptan/naproxen sodium)
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subject is between 12 and 17 years old at the Screening visit. * If subject is female, she must have a negative urine pregnancy test at screening, does not plan to become pregnant during the course of the study and agrees to use an acceptable method of birth control (i.e., a method with a failure rate \<1% or abstinence) if she is/becomes sexually active. * Subject has migraine with or without aura (2004 ICHD-II criteria). * Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours (untreated, or unsuccessfully treated). * Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the Screening visit. * Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine. * Subject is able to distinguish migraine from other headaches (e.g., tension-type headaches). * Subject and subject's parent or legal guardian are willing and able to provide informed consent prior to entry into this treatment phase of the study. * Subject and subject's parent or legal guardian are able to read and write English or Spanish. * Subject is able to understand and complete the electronic device to report treatment information.
Exclusion criteria
* Subject is \< 75 pounds (33.3kg). * Subject has ≥15 headache days per month in total, retinal (ICHD-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches. * Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (See Appendix 1, section 11.1). * Subject has uncontrolled hypertension (See Appendix 2, section 11.2) or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker. * 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. * Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of the above. * 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. * Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study. * 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. * Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; 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. * Subject has a recent history of regular use of opioids or barbiturates for treatment of his/her 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. * 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 2 weeks prior to screening through 2 weeks post final study treatment. * Subject history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent. * Subject has evidence or history of any gastrointestinal surgery or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease. * 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. * Subject has participated in an 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 With the Indicated Drug-related Adverse Events | Baseline through End of Study (up to Month 12) | The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: \>=2% participants recorded as having at least one occurrence of a reported drug-related AE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event Categorized by Severity | Baseline through End of Study (up to Month 12) | The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded. |
| Number of Participants With Any Adverse Event Categorized Over Time | Baseline through End of Study (up to Month 12) | The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; \<=194 days) or the second six months of the study (months 6-12; =\>194 days until end of study) was recorded. |
| Number of Participants With Any Adverse Event Categorized by Participant Age | Baseline through End of Study (up to Month 12) | The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded. |
| Number of Participants With Any Adverse Event Categorized by Participant Race | Baseline through End of Study (up to Month 12) | The number of participants with any adverse event was categorized by race. The category Other captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White. |
| Number of Participants With Any Adverse Event Categorized by Participant Gender | Baseline through End of Study (up to Month 12) | The number of participants with adverse events by gender is recorded. |
| Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Baseline through End of Study (up to Month 12) | The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively. |
| Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Baseline through End of Study (up to Month 12) | A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), \>13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, \>13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), \>13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), \>13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL). |
| Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Baseline through End of Study (up to Month 12) | A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490. |
| Mean Height for All Study Participants at the Indicated Time Points | Screening and Months 3, 6, 9, and 12 | — |
| Mean Weight for All Study Participants at the Indicated Time Points | Screening and Months 3, 6, 9, and 12 | — |
| Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Screening and Months 3, 6, 9, and 12 | BMI = (Weight in kilograms)/(height in centimeters/100)\^2 |
| Mean Blood Pressure for All Study Participants at the Indicated Time Points | Screening and Months 3, 6, 9, and 12 | At each visit, a participant's blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure. |
| Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Baseline through End of Study (up to Month 12) | The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded. |
| Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening and Final Visit (up to Month 12) | The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator. |
| Number of Treated Migraine Attacks | Baseline through End of Study (up to Month 12) | The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John's Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet. |
| Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet | Baseline through End of Study (up to Month 12) | The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending \<= 24 hours after the participant was dosed with the Combination Tablet. |
| Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet | Baseline through End of Study (up to Month 12) | The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending \<= 4 hours after the participant was dosed with the Combination Tablet. |
| Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet | Baseline through End of Study (up to Month 12) | The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending \<= 4 hours after the participant was dosed with the Combination Tablet. |
| Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Baseline through End of Study (up to Month 12) | The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet. |
| Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet | Baseline through End of Study (up to Month 12) | The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized. |
| Number of Migraine Attacks Rated With the Indicated Pain Severity | Baseline through End of Study (up to Month 12) | The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe. |
| Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Baseline through End of Study (up to Month 12) | The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound. |
| Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Baseline and Months 3, 6, 9, and 12 | The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status. |
| Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Screening | The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7). |
| Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | End of Study/Month 12 | The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7). |
| Mean Heart Rate for All Study Participants at the Indicated Time Points | Screening and Months 3, 6, 9, and 12 | A sitting heart rate was measured once for each participant at each visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 85 mg Sumatriptan/500 mg Naproxen Sodium Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium. | 622 |
| Total | 622 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 41 |
| Overall Study | Did not meet criteria for treatment | 30 |
| Overall Study | Increased use of concomitant medication | 1 |
| Overall Study | Increase in number of migraines | 2 |
| Overall Study | Investigator decision | 1 |
| Overall Study | Lack of Efficacy | 28 |
| Overall Study | Lost to Follow-up | 44 |
| Overall Study | Participant had too few migraines | 5 |
| Overall Study | Postive drug screen | 1 |
| Overall Study | Protocol Violation | 32 |
| Overall Study | Withdrawal by Subject | 106 |
| Overall Study | Withdrawn per medical monitor decision | 2 |
Baseline characteristics
| Characteristic | 85 mg Sumatriptan/500 mg Naproxen Sodium |
|---|---|
| Age, Continuous | 14.7 Years STANDARD_DEVIATION 1.68 |
| Race/Ethnicity, Customized African American/African Heritage and Asian | 2 participants |
| Race/Ethnicity, Customized African American/African Heritage and White | 3 participants |
| Race/Ethnicity, Customized Africian American | 71 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 10 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native and White | 5 participants |
| Race/Ethnicity, Customized Asian | 4 participants |
| Race/Ethnicity, Customized Caucasian | 527 participants |
| Sex: Female, Male Female | 367 Participants |
| Sex: Female, Male Male | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 257 / 622 | 159 / 333 | 89 / 181 |
| serious Total, serious adverse events | 4 / 622 | 3 / 333 | 1 / 181 |
Outcome results
Primary
Number of Participants With the Indicated Drug-related Adverse Events
The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: \>=2% participants recorded as having at least one occurrence of a reported drug-related AE.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | At least one drug-related adverse event | 93 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Nausea | 19 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Dizziness | 7 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Muscle tightness | 10 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Chest discomfort | 10 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Paresthesia | 8 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Throat tightness | 11 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Somnolence | 9 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Neck pain | 6 participants |
| 6 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Flushing | 5 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Neck pain | 3 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | At least one drug-related adverse event | 46 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Paresthesia | 2 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Chest discomfort | 3 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Nausea | 11 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Flushing | 2 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Somnolence | 2 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Dizziness | 3 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Throat tightness | 6 participants |
| 12 Month Completer Population | Number of Participants With the Indicated Drug-related Adverse Events | Muscle tightness | 5 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Somnolence | 14 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Muscle tightness | 18 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Chest discomfort | 16 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Paresthesia | 14 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Neck pain | 12 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Throat tightness | 14 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | At least one drug-related adverse event | 170 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Flushing | 8 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Nausea | 44 participants |
| Safety Population | Number of Participants With the Indicated Drug-related Adverse Events | Dizziness | 20 participants |
Secondary
Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month
The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Month Completer Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Migraines | 2.2 events | Standard Deviation 1.17 |
| 6 Month Completer Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Headaches | 3.3 events | Standard Deviation 2.19 |
| 6 Month Completer Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Treated migraine attacks | 1.9 events | Standard Deviation 1.05 |
| 12 Month Completer Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Migraines | 2.6 events | Standard Deviation 1.09 |
| 12 Month Completer Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Headaches | 3.9 events | Standard Deviation 2.29 |
| 12 Month Completer Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Treated migraine attacks | 2.4 events | Standard Deviation 0.97 |
| Safety Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Headaches | 3.0 events | Standard Deviation 2.49 |
| Safety Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Treated migraine attacks | 1.5 events | Standard Deviation 1.11 |
| Safety Population | Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month | Migraines | 1.8 events | Standard Deviation 1.23 |
Secondary
Mean Blood Pressure for All Study Participants at the Indicated Time Points
At each visit, a participant's blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure.
Time frame: Screening and Months 3, 6, 9, and 12
Population: Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Screening, n=285, 337, 622 | 107.4 millimeters of mercury (mmHg) | Standard Deviation 10.08 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 3, n=270, 308, 578 | 107.2 millimeters of mercury (mmHg) | Standard Deviation 10.67 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 6, n=224, 249, 473 | 109.2 millimeters of mercury (mmHg) | Standard Deviation 10.37 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 9, n=198, 221, 419 | 109.6 millimeters of mercury (mmHg) | Standard Deviation 10.55 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 12, n=178, 198, 376 | 111.0 millimeters of mercury (mmHg) | Standard Deviation 10.78 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Screening, n=285, 337, 622 | 66.2 millimeters of mercury (mmHg) | Standard Deviation 7.72 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 3, n=270, 308, 578 | 65.7 millimeters of mercury (mmHg) | Standard Deviation 7.33 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 6, n=224, 249, 473 | 66.1 millimeters of mercury (mmHg) | Standard Deviation 7.29 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 9, n=198, 221, 419 | 65.6 millimeters of mercury (mmHg) | Standard Deviation 6.79 |
| 6 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 12, n=178, 198, 376 | 66.6 millimeters of mercury (mmHg) | Standard Deviation 8.4 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 9, n=198, 221, 419 | 68.9 millimeters of mercury (mmHg) | Standard Deviation 7.3 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Screening, n=285, 337, 622 | 110.2 millimeters of mercury (mmHg) | Standard Deviation 10.15 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Screening, n=285, 337, 622 | 69.0 millimeters of mercury (mmHg) | Standard Deviation 7.24 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 12, n=178, 198, 376 | 112.1 millimeters of mercury (mmHg) | Standard Deviation 10.22 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 3, n=270, 308, 578 | 111.1 millimeters of mercury (mmHg) | Standard Deviation 10.19 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 12, n=178, 198, 376 | 69.9 millimeters of mercury (mmHg) | Standard Deviation 7.35 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 6, n=224, 249, 473 | 68.4 millimeters of mercury (mmHg) | Standard Deviation 7.68 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 6, n=224, 249, 473 | 112.0 millimeters of mercury (mmHg) | Standard Deviation 10.39 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 3, n=270, 308, 578 | 68.4 millimeters of mercury (mmHg) | Standard Deviation 7.84 |
| 12 Month Completer Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 9, n=198, 221, 419 | 112.7 millimeters of mercury (mmHg) | Standard Deviation 10.63 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 6, n=224, 249, 473 | 67.3 millimeters of mercury (mmHg) | Standard Deviation 7.58 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 9, n=198, 221, 419 | 111.2 millimeters of mercury (mmHg) | Standard Deviation 10.69 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 12, n=178, 198, 376 | 111.5 millimeters of mercury (mmHg) | Standard Deviation 10.49 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Screening, n=285, 337, 622 | 67.7 millimeters of mercury (mmHg) | Standard Deviation 7.58 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 9, n=198, 221, 419 | 67.3 millimeters of mercury (mmHg) | Standard Deviation 7.25 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 3, n=270, 308, 578 | 67.1 millimeters of mercury (mmHg) | Standard Deviation 7.72 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Screening, n=285, 337, 622 | 108.9 millimeters of mercury (mmHg) | Standard Deviation 10.21 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | DBP, Month 12, n=178, 198, 376 | 68.3 millimeters of mercury (mmHg) | Standard Deviation 8.03 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 3, n=270, 308, 578 | 109.3 millimeters of mercury (mmHg) | Standard Deviation 10.58 |
| Safety Population | Mean Blood Pressure for All Study Participants at the Indicated Time Points | SBP, Month 6, n=224, 249, 473 | 110.6 millimeters of mercury (mmHg) | Standard Deviation 10.46 |
Secondary
Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points
BMI = (Weight in kilograms)/(height in centimeters/100)\^2
Time frame: Screening and Months 3, 6, 9, and 12
Population: Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 9, n= 197, 220, 417 | 22.58 kilograms per meters squared | Standard Deviation 4.904 |
| 6 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 6, n=223, 248, 471 | 22.54 kilograms per meters squared | Standard Deviation 4.949 |
| 6 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 22.01 kilograms per meters squared | Standard Deviation 4.611 |
| 6 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 3, n=270, 306, 576 | 22.09 kilograms per meters squared | Standard Deviation 4.74 |
| 6 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 22.81 kilograms per meters squared | Standard Deviation 4.969 |
| 12 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 6, n=223, 248, 471 | 23.74 kilograms per meters squared | Standard Deviation 5.455 |
| 12 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 23.77 kilograms per meters squared | Standard Deviation 5.249 |
| 12 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 3, n=270, 306, 576 | 23.71 kilograms per meters squared | Standard Deviation 5.267 |
| 12 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 9, n= 197, 220, 417 | 23.74 kilograms per meters squared | Standard Deviation 5.431 |
| 12 Month Completer Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 23.79 kilograms per meters squared | Standard Deviation 5.633 |
| Safety Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 23.33 kilograms per meters squared | Standard Deviation 5.345 |
| Safety Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 9, n= 197, 220, 417 | 23.20 kilograms per meters squared | Standard Deviation 5.215 |
| Safety Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 22.97 kilograms per meters squared | Standard Deviation 5.04 |
| Safety Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 6, n=223, 248, 471 | 23.17 kilograms per meters squared | Standard Deviation 5.251 |
| Safety Population | Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points | Month 3, n=270, 306, 576 | 22.95 kilograms per meters squared | Standard Deviation 5.087 |
Secondary
Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12
The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status.
Time frame: Baseline and Months 3, 6, 9, and 12
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role restrictive, Month 3, n=457, 160 | 10.1 points on a scale | Standard Error 1.145 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role restrictive, Month 6, n=366, 160 | 10.5 points on a scale | Standard Error 1.302 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role restrictive, Month 9, n=315, 148 | 13.7 points on a scale | Standard Error 1.475 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role restrictive, Month 12, n=291, 153 | 15.7 points on a scale | Standard Error 1.53 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role preventative, Month 3, n=457, 160 | 7.9 points on a scale | Standard Error 1.11 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role preventative, Month 6, n=366, 160 | 6.8 points on a scale | Standard Error 1.212 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role preventative, Month 9, n=315, 148 | 9.4 points on a scale | Standard Error 1.473 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role preventative, Month 12, n=291, 153 | 9.8 points on a scale | Standard Error 1.441 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role emotional , Month 3, n=457, 160 | 7.1 points on a scale | Standard Error 1.287 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role emotional, Month 6, n=366, 160 | 6.6 points on a scale | Standard Error 1.441 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role emotional, Month 9, n=315, 148 | 10.5 points on a scale | Standard Error 1.625 |
| 6 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role emotional, Month 12, n=291, 153 | 11.4 points on a scale | Standard Error 1.694 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role emotional, Month 9, n=315, 148 | 9.0 points on a scale | Standard Error 2.411 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role restrictive, Month 3, n=457, 160 | 9.0 points on a scale | Standard Error 1.952 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role preventative, Month 9, n=315, 148 | 8.2 points on a scale | Standard Error 2.234 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role restrictive, Month 6, n=366, 160 | 8.2 points on a scale | Standard Error 1.972 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role emotional, Month 6, n=366, 160 | 7.2 points on a scale | Standard Error 2.136 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role restrictive, Month 9, n=315, 148 | 9.0 points on a scale | Standard Error 2.155 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role preventative, Month 12, n=291, 153 | 8.4 points on a scale | Standard Error 1.959 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role restrictive, Month 12, n=291, 153 | 11.5 points on a scale | Standard Error 2.117 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role emotional, Month 12, n=291, 153 | 7.1 points on a scale | Standard Error 2.461 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role preventative, Month 3, n=457, 160 | 9.6 points on a scale | Standard Error 1.974 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role emotional , Month 3, n=457, 160 | 7.9 points on a scale | Standard Error 2.223 |
| 12 Month Completer Population | Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 | Role preventative, Month 6, n=366, 160 | 8.3 points on a scale | Standard Error 1.89 |
Secondary
Mean Heart Rate for All Study Participants at the Indicated Time Points
A sitting heart rate was measured once for each participant at each visit.
Time frame: Screening and Months 3, 6, 9, and 12
Population: Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 9, n=198, 221, 419 | 76.9 beats per minute | Standard Deviation 11.43 |
| 6 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Screening, n=284, 336, 620 | 75.8 beats per minute | Standard Deviation 11.58 |
| 6 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 3, n=266, 305, 571 | 76.9 beats per minute | Standard Deviation 11.57 |
| 6 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 6, n=221, 247, 468 | 77.5 beats per minute | Standard Deviation 10.87 |
| 6 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 76.8 beats per minute | Standard Deviation 12.17 |
| 12 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 3, n=266, 305, 571 | 75.6 beats per minute | Standard Deviation 11.57 |
| 12 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 74.7 beats per minute | Standard Deviation 10.41 |
| 12 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 6, n=221, 247, 468 | 75.4 beats per minute | Standard Deviation 10.22 |
| 12 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 9, n=198, 221, 419 | 75.4 beats per minute | Standard Deviation 11.13 |
| 12 Month Completer Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Screening, n=284, 336, 620 | 73.0 beats per minute | Standard Deviation 10.2 |
| Safety Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Screening, n=284, 336, 620 | 7.43 beats per minute | Standard Deviation 10.93 |
| Safety Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 3, n=266, 305, 571 | 76.2 beats per minute | Standard Deviation 11.58 |
| Safety Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 9, n=198, 221, 419 | 76.1 beats per minute | Standard Deviation 11.28 |
| Safety Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 75.7 beats per minute | Standard Deviation 11.31 |
| Safety Population | Mean Heart Rate for All Study Participants at the Indicated Time Points | Month 6, n=221, 247, 468 | 76.4 beats per minute | Standard Deviation 10.57 |
Secondary
Mean Height for All Study Participants at the Indicated Time Points
Time frame: Screening and Months 3, 6, 9, and 12
Population: Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary by visit, depending on the number of assessments completed at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Month 9, n=198, 221, 419 | 163.8 centimeters | Standard Deviation 8.92 |
| 6 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Month 6, n=224, 249, 473 | 162.6 centimeters | Standard Deviation 9.12 |
| 6 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 160.2 centimeters | Standard Deviation 9.15 |
| 6 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Month 3, n=271, 308, 579 | 161.3 centimeters | Standard Deviation 9.09 |
| 6 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 165.3 centimeters | Standard Deviation 8.86 |
| 12 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Month 6, n=224, 249, 473 | 167.3 centimeters | Standard Deviation 8.81 |
| 12 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 167.0 centimeters | Standard Deviation 8.8 |
| 12 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Month 3, n=271, 308, 579 | 167.3 centimeters | Standard Deviation 8.92 |
| 12 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Month 9, n=198, 221, 419 | 167.6 centimeters | Standard Deviation 8.39 |
| 12 Month Completer Population | Mean Height for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 167.9 centimeters | Standard Deviation 8.7 |
| Safety Population | Mean Height for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 166.7 centimeters | Standard Deviation 8.86 |
| Safety Population | Mean Height for All Study Participants at the Indicated Time Points | Month 9, n=198, 221, 419 | 165.8 centimeters | Standard Deviation 8.84 |
| Safety Population | Mean Height for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 163.9 centimeters | Standard Deviation 9.57 |
| Safety Population | Mean Height for All Study Participants at the Indicated Time Points | Month 6, n=224, 249, 473 | 165.1 centimeters | Standard Deviation 9.26 |
| Safety Population | Mean Height for All Study Participants at the Indicated Time Points | Month 3, n=271, 308, 579 | 164.5 centimeters | Standard Deviation 9.48 |
Secondary
Mean Weight for All Study Participants at the Indicated Time Points
Time frame: Screening and Months 3, 6, 9, and 12
Population: Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 6 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 9, n=197, 220, 417 | 61.24 kilograms | Standard Deviation 17.149 |
| 6 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 6, n=223, 248, 471 | 60.20 kilograms | Standard Deviation 16.976 |
| 6 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 57.02 kilograms | Standard Deviation 15.45 |
| 6 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 3, n=270, 306, 576 | 58.01 kilograms | Standard Deviation 16.012 |
| 6 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 62.92 kilograms | Standard Deviation 17.406 |
| 12 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 6, n=223, 248, 471 | 66.61 kilograms | Standard Deviation 16.864 |
| 12 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 66.57 kilograms | Standard Deviation 16.824 |
| 12 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 3, n=270, 306, 576 | 66.61 kilograms | Standard Deviation 16.921 |
| 12 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 9, n=197, 220, 417 | 66.90 kilograms | Standard Deviation 17.169 |
| 12 Month Completer Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 67.35 kilograms | Standard Deviation 17.952 |
| Safety Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 12, n=178, 198, 376 | 65.25 kilograms | Standard Deviation 17.81 |
| Safety Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 9, n=197, 220, 417 | 64.23 kilograms | Standard Deviation 17.372 |
| Safety Population | Mean Weight for All Study Participants at the Indicated Time Points | Screening, n=285, 337, 622 | 62.19 kilograms | Standard Deviation 16.881 |
| Safety Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 6, n=223, 248, 471 | 63.57 kilograms | Standard Deviation 17.2 |
| Safety Population | Mean Weight for All Study Participants at the Indicated Time Points | Month 3, n=270, 306, 576 | 62.58 kilograms | Standard Deviation 17.037 |
Secondary
Number of Migraine Attacks Rated With the Indicated Pain Severity
The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | No pain | 0 treated migraine attacks |
| 6 Month Completer Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Mild | 1373 treated migraine attacks |
| 6 Month Completer Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Moderate | 3555 treated migraine attacks |
| 6 Month Completer Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Severe | 2385 treated migraine attacks |
| 12 Month Completer Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Severe | 1686 treated migraine attacks |
| 12 Month Completer Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | No pain | 0 treated migraine attacks |
| 12 Month Completer Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Moderate | 2535 treated migraine attacks |
| 12 Month Completer Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Mild | 1009 treated migraine attacks |
| Safety Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Severe | 2759 treated migraine attacks |
| Safety Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Mild | 1619 treated migraine attacks |
| Safety Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | Moderate | 4132 treated migraine attacks |
| Safety Population | Number of Migraine Attacks Rated With the Indicated Pain Severity | No pain | 0 treated migraine attacks |
Secondary
Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12
The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7).
Time frame: End of Study/Month 12
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Very Dissatisfied | 3 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Dissatisfied | 1 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Neutral | 6 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Somewhat Dissatisfied | 12 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Very Dissatisfied | 0 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Satisfied | 75 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Dissatisfied | 5 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Very Satisfied | 55 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Dissatisfied | 1 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Neutral | 11 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Satisfied | 61 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Somewhat Satisfied | 13 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Somewhat Satisfied | 24 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Somewhat Satisfied | 20 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Very Dissatisfied | 1 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Satisfied | 76 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Neutral | 7 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Very Satisfied | 66 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Very Satisfied | 71 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Somewhat Dissatisfied | 2 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Treatment Satisfaction, Somewhat Dissatisfied | 3 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Neutral | 10 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Very Dissatisfied | 2 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Neutral | 5 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Very Dissatisfied | 1 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Very Satisfied | 59 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Satisfied | 63 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Somewhat Satisfied | 16 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Neutral | 5 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Somewhat Dissatisfied | 1 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Dissatisfied | 0 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Very Dissatisfied | 0 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Very Satisfied | 49 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Satisfied | 51 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Somewhat Satisfied | 21 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Somewhat Dissatisfied | 7 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Dissatisfied | 4 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Very Satisfied | 64 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Satisfied | 61 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Somewhat Satisfied | 10 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Treatment Satisfaction, Somewhat Dissatisfied | 3 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Dissatisfied | 0 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Somewhat Dissatisfied | 3 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Treatment Satisfaction, Somewhat Dissatisfied | 3 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Dissatisfied | 3 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Somewhat Dissatisfied | 1 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Neutral | 3 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Very Dissatisfied | 2 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Very Satisfied | 51 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Somewhat Satisfied | 12 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Very Dissatisfied | 1 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Satisfied | 47 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Satisfied | 46 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Dissatisfied | 0 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Somewhat Satisfied | 6 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Satisfied | 40 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Very Satisfied | 48 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Somewhat Satisfied | 14 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Very Satisfied | 42 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Very Dissatisfied | 0 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Side Effects, Neutral | 6 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Efficacy, Dissatisfied | 0 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12 | Overall Treatment Satisfaction, Neutral | 2 participants |
Secondary
Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit
The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7).
Time frame: Screening
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. Due to data collection and/or assignment of a collected assessment to a visit, the number of participants analyzed at a given visit could vary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Satisfied | 192 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Very Satisfied | 135 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Very Dissatisfied | 15 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Very Dissatisfied | 11 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Satisfied | 166 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Very Satisfied | 50 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Dissatisfied | 18 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Somewhat Satisfied | 77 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Neutral | 67 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Somewhat Dissatisfied | 29 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Neutral | 127 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Satisfied | 163 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Treatment Satisfaction, Somewhat Dissatisfied | 31 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Somewhat Dissatisfied | 49 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Very Satisfied | 36 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Neutral | 67 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Dissatisfied | 43 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Dissatisfied | 43 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Somewhat Satisfied | 164 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Very Dissatisfied | 12 participants |
| 6 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Somewhat Satisfied | 192 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Treatment Satisfaction, Somewhat Dissatisfied | 13 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Very Satisfied | 22 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Satisfied | 102 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Somewhat Satisfied | 113 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Neutral | 30 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Somewhat Dissatisfied | 23 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Dissatisfied | 22 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Very Dissatisfied | 4 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Very Satisfied | 89 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Satisfied | 87 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Somewhat Satisfied | 45 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Neutral | 69 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Somewhat Dissatisfied | 13 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Dissatisfied | 6 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Very Dissatisfied | 7 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Very Satisfied | 30 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Satisfied | 113 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Somewhat Satisfied | 94 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Neutral | 35 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Dissatisfied | 23 participants |
| 12 Month Completer Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Very Dissatisfied | 8 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Very Dissatisfied | 4 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Satisfied | 54 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Very Satisfied | 11 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Very Dissatisfied | 2 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Very Dissatisfied | 3 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Satisfied | 70 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Dissatisfied | 8 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Dissatisfied | 9 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Somewhat Satisfied | 56 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Somewhat Dissatisfied | 12 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Very Satisfied | 11 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Treatment Satisfaction, Neutral | 16 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Neutral | 36 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Somewhat Satisfied | 26 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Neutral | 15 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Somewhat Dissatisfied | 6 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Satisfied | 50 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Overall Efficacy, Somewhat Satisfied | 72 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Dissatisfied | 2 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Side Effects, Very Satisfied | 50 participants |
| Safety Population | Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit | Treatment Satisfaction, Somewhat Dissatisfied | 9 participants |
Secondary
Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator
The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator.
Time frame: Screening and Final Visit (up to Month 12)
Population: Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, abnormal, CS, n=284, 337, 621 | 0 participants |
| 6 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, normal, n=284, 337, 621 | 224 participants |
| 6 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, Normal, n=248, 294, 542 | 196 participants |
| 6 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, abnormal, CS, n=248, 294, 542 | 0 participants |
| 6 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, abnormal, NCS, n=284, 337, 621 | 60 participants |
| 6 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, abnormal, NCS, n=248, 294, 542 | 52 participants |
| 12 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, abnormal, NCS, n=284, 337, 621 | 67 participants |
| 12 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, normal, n=284, 337, 621 | 270 participants |
| 12 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, abnormal, CS, n=284, 337, 621 | 0 participants |
| 12 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, Normal, n=248, 294, 542 | 220 participants |
| 12 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, abnormal, NCS, n=248, 294, 542 | 74 participants |
| 12 Month Completer Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, abnormal, CS, n=248, 294, 542 | 0 participants |
| Safety Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, abnormal, NCS, n=284, 337, 621 | 127 participants |
| Safety Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, abnormal, CS, n=248, 294, 542 | 0 participants |
| Safety Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, abnormal, NCS, n=248, 294, 542 | 126 participants |
| Safety Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, abnormal, CS, n=284, 337, 621 | 0 participants |
| Safety Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Screening, normal, n=284, 337, 621 | 494 participants |
| Safety Population | Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator | Final Visit, Normal, n=248, 294, 542 | 416 participants |
Secondary
Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit
A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), \>13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, \>13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), \>13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), \>13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL).
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | ALT, normal to high, n=330, 179, 565 | 2 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | ALT, normal to low, n=330, 179, 565 | 0 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | AST, normal to high, n=329, 179, 562 | 1 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | AST, normal to low, n=329, 179, 562 | 0 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Creatinine, normal to high, n=330, 179, 565 | 0 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Creatinine, normal to low, n=330, 179, 565 | 2 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Potassium, normal to high, n=329, 179, 562 | 1 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Potassium, normal to low, n=329, 179, 562 | 3 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | BUN, normal to high, n=330, 179, 565 | 0 participants |
| 6 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | BUN, normal to low, n=330, 179, 565 | 2 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | BUN, normal to high, n=330, 179, 565 | 0 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | ALT, normal to high, n=330, 179, 565 | 1 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Creatinine, normal to low, n=330, 179, 565 | 1 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Creatinine, normal to high, n=330, 179, 565 | 0 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | ALT, normal to low, n=330, 179, 565 | 0 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | BUN, normal to low, n=330, 179, 565 | 0 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Potassium, normal to low, n=329, 179, 562 | 2 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | AST, normal to high, n=329, 179, 562 | 1 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Potassium, normal to high, n=329, 179, 562 | 0 participants |
| 12 Month Completer Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | AST, normal to low, n=329, 179, 562 | 0 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Potassium, normal to low, n=329, 179, 562 | 6 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | AST, normal to low, n=329, 179, 562 | 0 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Creatinine, normal to high, n=330, 179, 565 | 0 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Creatinine, normal to low, n=330, 179, 565 | 2 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | BUN, normal to high, n=330, 179, 565 | 1 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Potassium, normal to high, n=329, 179, 562 | 4 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | ALT, normal to high, n=330, 179, 565 | 3 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | BUN, normal to low, n=330, 179, 565 | 9 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | ALT, normal to low, n=330, 179, 565 | 0 participants |
| Safety Population | Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | AST, normal to high, n=329, 179, 562 | 3 participants |
Secondary
Number of Participants With Any Adverse Event Categorized by Participant Age
The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Age | Ages 12-14 | 104 participants |
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Age | Ages 15-17 | 135 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Age | Ages 12-14 | 57 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Age | Ages 15-17 | 73 participants |
| Safety Population | Number of Participants With Any Adverse Event Categorized by Participant Age | Ages 12-14 | 175 participants |
| Safety Population | Number of Participants With Any Adverse Event Categorized by Participant Age | Ages 15-17 | 218 participants |
Secondary
Number of Participants With Any Adverse Event Categorized by Participant Gender
The number of participants with adverse events by gender is recorded.
Time frame: Baseline through End of Study (up to Month 12)
Population: Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Gender | Female | 238 participants |
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Gender | Male | 155 participants |
Secondary
Number of Participants With Any Adverse Event Categorized by Participant Race
The number of participants with any adverse event was categorized by race. The category Other captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White.
Time frame: Baseline through End of Study (up to Month 12)
Population: Safety Population: all participants in the Enrolled Population who took at least one dose of the combination tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Race | Caucasian | 344 participants |
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Race | African American | 35 participants |
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Participant Race | Other | 14 participants |
Secondary
Number of Participants With Any Adverse Event Categorized by Severity
The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Severity | Moderate | 140 participants |
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Severity | Mild | 74 participants |
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Severity | Severe | 24 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Severity | Moderate | 72 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Severity | Mild | 43 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event Categorized by Severity | Severe | 14 participants |
| Safety Population | Number of Participants With Any Adverse Event Categorized by Severity | Mild | 127 participants |
| Safety Population | Number of Participants With Any Adverse Event Categorized by Severity | Severe | 44 participants |
| Safety Population | Number of Participants With Any Adverse Event Categorized by Severity | Moderate | 220 participants |
Secondary
Number of Participants With Any Adverse Event Categorized Over Time
The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; \<=194 days) or the second six months of the study (months 6-12; =\>194 days until end of study) was recorded.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized Over Time | First six months of study | 208 participants |
| 6 Month Completer Population | Number of Participants With Any Adverse Event Categorized Over Time | Second six months of study | 143 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event Categorized Over Time | First six months of study | 112 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event Categorized Over Time | Second six months of study | 85 participants |
| Safety Population | Number of Participants With Any Adverse Event Categorized Over Time | First six months of study | 348 participants |
| Safety Population | Number of Participants With Any Adverse Event Categorized Over Time | Second six months of study | 191 participants |
Secondary
Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet
The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Within 3 days | 66 participants |
| 6 Month Completer Population | Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Within 5 days | 66 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Within 3 days | 35 participants |
| 12 Month Completer Population | Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Within 5 days | 35 participants |
| Safety Population | Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Within 3 days | 128 participants |
| Safety Population | Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet | Within 5 days | 130 participants |
Secondary
Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit
A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet. The number of participants with an assessment may vary, depending on the number of assessments completed at each visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hemoglobin, normal to high, n=318,176, 546 | 6 participants |
| 6 Month Completer Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hemoglobin, normal to low, n=318,176, 546 | 10 participants |
| 6 Month Completer Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hematocrit, normal to high, n=318,176, 546 | 2 participants |
| 6 Month Completer Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hematocrit, normal to low, n=318,176, 546 | 17 participants |
| 12 Month Completer Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hematocrit, normal to low, n=318,176, 546 | 10 participants |
| 12 Month Completer Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hemoglobin, normal to high, n=318,176, 546 | 0 participants |
| 12 Month Completer Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hematocrit, normal to high, n=318,176, 546 | 0 participants |
| 12 Month Completer Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hemoglobin, normal to low, n=318,176, 546 | 6 participants |
| Safety Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hematocrit, normal to low, n=318,176, 546 | 29 participants |
| Safety Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hemoglobin, normal to low, n=318,176, 546 | 20 participants |
| Safety Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hematocrit, normal to high, n=318,176, 546 | 4 participants |
| Safety Population | Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit | Hemoglobin, normal to high, n=318,176, 546 | 9 participants |
Secondary
Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet
The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Number of tablets with an AE within 3 days | 917 tablets |
| 6 Month Completer Population | Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Number of tablets with an AE within 5 days | 970 tablets |
| 12 Month Completer Population | Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Number of tablets with an AE within 3 days | 667 tablets |
| 12 Month Completer Population | Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Number of tablets with an AE within 5 days | 706 tablets |
| Safety Population | Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Number of tablets with an AE within 3 days | 1116 tablets |
| Safety Population | Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet | Number of tablets with an AE within 5 days | 1178 tablets |
Secondary
Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet
The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet | Total Migraines | 8290 migraine attacks |
| 6 Month Completer Population | Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet | Treated Migraines | 7318 migraine attacks |
| 12 Month Completer Population | Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet | Total Migraines | 5851 migraine attacks |
| 12 Month Completer Population | Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet | Treated Migraines | 5234 migraine attacks |
| Safety Population | Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet | Total Migraines | 9937 migraine attacks |
| Safety Population | Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet | Treated Migraines | 8517 migraine attacks |
Secondary
Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet
The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending \<= 24 hours after the participant was dosed with the Combination Tablet.
Time frame: Baseline through End of Study (up to Month 12)
Population: ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet | All Migraines | 6400 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet | Migraines Without Rescue Medication | 6142 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet | Migraines Without Rescue or Prohibited Medication | 6052 treated migraine attacks |
Secondary
Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet
The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending \<= 4 hours after the participant was dosed with the Combination Tablet.
Time frame: Baseline through End of Study (up to Month 12)
Population: ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet | All Migraines | 5076 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet | Migraines Without Rescue Medication | 5020 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet | Migraines Without Rescue or Prohibited Medication | 5017 treated migraine attacks |
Secondary
Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet
The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending \<= 4 hours after the participant was dosed with the Combination Tablet.
Time frame: Baseline through End of Study (up to Month 12)
Population: ITT Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet | All Migraines | 3623 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet | Migraines Without Rescue Medication | 3598 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet | Migraines Without Rescue or Prohibited Medication | 3596 treated migraine attacks |
Secondary
Number of Treated Migraine Attacks
The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John's Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet.
Time frame: Baseline through End of Study (up to Month 12)
Population: Intent-to-Treat (ITT) Population: all participants who took at least one dose of study drug and had at least one post-treatment migraine assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Treated Migraine Attacks | All Migraines | 8517 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Migraine Attacks | Migraines Without Rescue Medication | 7791 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Migraine Attacks | Migraines Without Rescue or Prohibited Medication | 7657 treated migraine attacks |
Secondary
Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting
The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound.
Time frame: Baseline through End of Study (up to Month 12)
Population: Enrolled Population: all participants entered into the trial and dispensed the Combination Tablet, regardless of whether they ever took the Combination Tablet
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Sinus pain | 2052 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Nausea | 3120 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Vomiting | 555 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Photophobia | 5608 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Neck pain | 3050 treated migraine attacks |
| 6 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Phonophobia | 5221 treated migraine attacks |
| 12 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Neck pain | 2172 treated migraine attacks |
| 12 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Sinus pain | 1424 treated migraine attacks |
| 12 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Phonophobia | 3725 treated migraine attacks |
| 12 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Vomiting | 375 treated migraine attacks |
| 12 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Photophobia | 4064 treated migraine attacks |
| 12 Month Completer Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Nausea | 2173 treated migraine attacks |
| Safety Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Vomiting | 682 treated migraine attacks |
| Safety Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Photophobia | 6528 treated migraine attacks |
| Safety Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Phonophobia | 6063 treated migraine attacks |
| Safety Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Nausea | 3690 treated migraine attacks |
| Safety Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Neck pain | 3540 treated migraine attacks |
| Safety Population | Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting | Sinus pain | 2428 treated migraine attacks |