Migraine, Acute, Migraine Disorders
Conditions
Keywords
Migraine, acute, Migraine, Butalbital-containing Combination Medication (BCM), Naproxen sodium, Sumatriptan succinate, TREXIMET®
Brief summary
Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)
Detailed description
This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMET® will be compared to a butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg \[Fioricet\]) for the acute treatment of migraine headaches. Subjects will be randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT where T = TREXIMET®; P = Placebo; B = Butalbital-containing Combination Medication) . Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. The study will include 4 visits: (1) a Screening visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, and (4) a Final visit. The Final visit occurs either (A) upon withdrawal or (B) after treatment of 3 migraine attacks. The primary objective is to evaluate the efficacy of TREXIMET® versus BCM for the acute treatment of moderate/severe migraine. These two replicate studies were amended while ongoing to allow for the reporting of pooled data only.
Interventions
DRUGTREXIMET®
Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)
DRUGButalbital-containing Combination Medications (BCM)
butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]
DRUGplacebo
placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18 to 65 years. Female subjects are eligible for participation if they are either of non-childbearing potential (not capable of becoming pregnant) OR of childbearing potential having a negative urine pregnancy test at screening, and using contraception if sexually active. If using oral contraceptives, the subjects should be on a stable regimen of oral contraceptives (\>/= 2 months). Eligible subjects must: * have migraine with or without aura (2004 ICHD-II criteria) and must have had at least 2 attacks per month meeting these criteria in the three months prior to screening. * have documented use of Butalbital-containing Combination Medication (MCM) to have treated at least one migraine. * be able to understand how to complete the cognitive assessments and all other questionnaires programmed in an electronic diary. * be willing and able to provide written informed consent.
Exclusion criteria
A subject is not eligible if they have: * \>8 migraines or \>/= 15 headache days per month in total, or has retinal, basilar, or hemiplegic migraine, or secondary headaches. * taken \>350mg/day of butalbital and/or other barbiturates on an equivalent dose basis, on average, over the 30 days prior to screening. * is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or risk factors). * blood pressure \>/= 140/90mmHg in 2 out of 3 BP measurements or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker. * history of congenital heart disease, cardiac arrhythmias requiring medication, or a clinical significant electrocardiogram abnormality. * evidence or history of any ischemic vascular disease including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with these. * 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. * a history of impaired hepatic or renal function that contraindicates participation in the study. * hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID, aspirin, barbiturates, or acetaminophen (including all sumatriptan and naproxen preparations), has porphyria or has nasal polyps and asthma. * is currently taking, or has taken in the previous three months, an ergot preparation for migraine prophylaxis; or is taking a migraine or prophylactic medication that is not stabilized (i.e. a change of dose within the last 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized. * a recent history of regular use of opioids (including opioids in combination with butalbital, e.g. Fioricet with codeine) or barbiturates other than butalbital. Regular use is defined as an average of 4 days per month over the last 6 months. * 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. * history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent (except low-dose aspirin \</= 325mg/day for cardioprotective reasons). * 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. * is pregnant, actively trying to become pregnant, breast feeding, or not willing to have pregnancy test performed. * evidence of alcohol or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgement, 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 study. * participated in an investigational drug trial within the previous four 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 a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for the first migraine attack treated. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it. |
| Number of Participants Using Rescue Medication Within 48 Hours Post Dose | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Number of participants who took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it. |
| Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their second migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it. |
| Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3) | From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their third migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it. |
| Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Migraine-free is defined as pain-free with no migraine-associated symptoms (nausea, vomiting, photophobia \[sensitivity to light\], and phonophobia \[sensitivity to sound\]) with use of any rescue medication before the defined time point. |
| Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of nausea in those participants for whom nausea was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
| Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of photophobia in those participants for whom photophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
| Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of phonophobia in those participants for whom phonophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
| Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of vomiting in those participants for whom vomiting was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
| Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of sinus/facial pain in those participants for whom sinus/facial pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
| Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Pain-Free is defined as having no pain and without the use of any rescue medication from the time of the initial dose of study medication for a particular migraine attack until the defined time point at 2, 4, 6, 8, 24 or 48 hours post-dose. |
| Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Pain relief is defined as having no or mild pain and no use of rescue medication after dosing in those participants who had moderate or severe pain at dosing. |
| Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Complete symptom-free is defined as migraine-free, neck pain-free, and sinus pain-free without the use of any rescue medication prior to the defined time point. |
| Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | At time of dosing, and at 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Overall cognition was assessed with a composite score (range 0-9) called the Performance Index, as derived from the number of correct responses per minute on subtests of the Mental Efficiency Workload Test (MEWT) cognitive battery. For a particular participant, lower scores indicate a negative impact, or worsened, general cognition; higher scores indicate improved cognition. |
| Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | Dose time, 2, 4, 6, 8, 24 and 48 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Participant alertness was evaluated with the 7-point modified SS scale, where 1 is feeling active, vital, alert, wide awake, 2 is still functioning at high levels, but not peak; able to concentrate, 3 is awake, but relaxed; responsive but not fully alert, 4 is somewhat foggy, let down, 5 is foggy, losing interest in remaining awake, 6 is sleepy, woozy, fighting sleep, prefer to lie down, and 7 is no longer fighting sleep, sleep onset soon, having dream like thoughts. |
| Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine | At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction. |
| Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction. |
| Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction. |
| Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction. |
| Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction. |
| Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | At dosing and at 2, 4, 6 and 8 hours after dosing of each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | Clinical disability for each participant was assessed using the CDQ. This scale uses one question to assess ability to perform normal or usual activities. Responses are recorded on a 5-point scale, where 1 is normal/not impaired, 2 is mildly impaired, 3 is moderately impaired, 4 is severely impaired, and 5 is 'required bedrest. |
| Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed). | The number of participants with no pain and relief of neck pain in those participants for whom neck pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point. |
Countries
United States
Participant flow
Recruitment details
Results for the TRX109011 (NCT00573170) and TRX109013 (NCT00599157) studies were pooled for analysis. Individual studies were not analyzed or reported separately. The individual protocols were amended while ongoing to allow for pooling of study data for analysis.
Pre-assignment details
Randomized participants were treated for three separate migraine attacks with three different investigational products, assigned in randomized order, as one of six possible treatment sequences. Not all participants enrolled in the study were randomized for treatment; those participants who were randomized are said to have started the study
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Treated at Least Once All study participants who were treated at least once with study medication | 442 |
| Total | 442 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| First Treatment Period | Did Not Treat Attack 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| First Washout Period | Adverse Event | 1 | 1 | 0 | 0 | 0 | 1 |
| First Washout Period | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 |
| First Washout Period | Lost to Follow-up | 1 | 1 | 0 | 2 | 0 | 2 |
| First Washout Period | Other | 4 | 0 | 1 | 1 | 0 | 0 |
| First Washout Period | Withdrawal by Subject | 2 | 0 | 0 | 2 | 3 | 3 |
| Second Washout Period | Adverse Event | 1 | 0 | 0 | 0 | 1 | 0 |
| Second Washout Period | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Second Washout Period | Other | 1 | 2 | 1 | 4 | 6 | 2 |
| Second Washout Period | Protocol Violation | 2 | 1 | 1 | 0 | 0 | 0 |
| Second Washout Period | Withdrawal by Subject | 1 | 1 | 2 | 0 | 1 | 0 |
| Third Treatment Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 2 |
| Third Treatment Period | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Participants Treated at Least Once |
|---|---|
| Age Continuous | 42.6 Years STANDARD_DEVIATION 11.23 |
| Race/Ethnicity, Customized African American/African Heritage | 61 participants |
| Race/Ethnicity, Customized American Indian or Native Alaskan | 1 participants |
| Race/Ethnicity, Customized Asian - Central/South | 2 participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 1 participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 2 participants |
| Race/Ethnicity, Customized Mixed Race | 4 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 2 participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 368 participants |
| Sex: Female, Male Female | 391 Participants |
| Sex: Female, Male Male | 51 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 | 8 / 405 | 8 / 406 | 2 / 392 |
| serious Total, serious adverse events | 1 / 405 | 2 / 406 | 0 / 392 |
Outcome results
Primary
Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose
SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.
Time frame: From 2 to 24 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: Intent-to-Treat (ITT) Population: all participants who were treated with investigational product and provided at least one post-dose efficacy assessment . Participants may have been included in one, two, or all of the Placebo, Treximet and Butalbital-containing combination medication arms due to the cross-over nature of the study design.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | 10 participants |
| Treximet | Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | 26 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose | 18 participants |
p-value: 0.37895% CI: [0.7, 2.5]Generalized Estimating Equations
Secondary
Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication
The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.
Time frame: At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population: those participants who provided any information for the PPMQ-R.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 88 scores on a scale | Standard Error 0.8 |
| Treximet | Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 86 scores on a scale | Standard Error 0.8 |
| Butalbital-containing Combination Medication | Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 89 scores on a scale | Standard Error 0.9 |
Secondary
Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication
The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.
Time frame: At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population: those participants who provided any information for the PPMQ-R.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 79 scores on a scale | Standard Error 1.3 |
| Treximet | Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 82 scores on a scale | Standard Error 1.3 |
| Butalbital-containing Combination Medication | Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 78 scores on a scale | Standard Error 1.3 |
Secondary
Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine
The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.
Time frame: At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population: those participants who provided any information for the PPMQ-R.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine | 55 scores on a scale | Standard Error 1.8 |
| Treximet | Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine | 62 scores on a scale | Standard Error 1.7 |
| Butalbital-containing Combination Medication | Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine | 56 scores on a scale | Standard Error 1.8 |
Secondary
Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication
The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.
Time frame: At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population: those participants who provided any information for the PPMQ-R.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 55 scores on a scale | Standard Error 1.9 |
| Treximet | Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 61 scores on a scale | Standard Error 1.8 |
| Butalbital-containing Combination Medication | Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 56 scores on a scale | Standard Error 1.9 |
Secondary
Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing
Overall cognition was assessed with a composite score (range 0-9) called the Performance Index, as derived from the number of correct responses per minute on subtests of the Mental Efficiency Workload Test (MEWT) cognitive battery. For a particular participant, lower scores indicate a negative impact, or worsened, general cognition; higher scores indicate improved cognition.
Time frame: At time of dosing, and at 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours | 7.33 scores on a scale | Standard Deviation 1.606 |
| Placebo | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours | 7.45 scores on a scale | Standard Deviation 1.666 |
| Placebo | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours | 7.38 scores on a scale | Standard Deviation 1.658 |
| Placebo | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | Dose time | 7.36 scores on a scale | Standard Deviation 1.598 |
| Placebo | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours | 7.78 scores on a scale | Standard Deviation 1.636 |
| Placebo | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours | 7.66 scores on a scale | Standard Deviation 1.524 |
| Placebo | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours | 7.44 scores on a scale | Standard Deviation 1.568 |
| Treximet | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours | 7.43 scores on a scale | Standard Deviation 1.532 |
| Treximet | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | Dose time | 7.29 scores on a scale | Standard Deviation 1.534 |
| Treximet | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours | 7.37 scores on a scale | Standard Deviation 1.568 |
| Treximet | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours | 7.50 scores on a scale | Standard Deviation 1.576 |
| Treximet | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours | 7.33 scores on a scale | Standard Deviation 1.632 |
| Treximet | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours | 7.82 scores on a scale | Standard Deviation 1.525 |
| Treximet | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours | 7.88 scores on a scale | Standard Deviation 1.351 |
| Butalbital-containing Combination Medication | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours | 7.33 scores on a scale | Standard Deviation 1.538 |
| Butalbital-containing Combination Medication | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours | 7.27 scores on a scale | Standard Deviation 1.579 |
| Butalbital-containing Combination Medication | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours | 7.69 scores on a scale | Standard Deviation 1.463 |
| Butalbital-containing Combination Medication | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours | 7.61 scores on a scale | Standard Deviation 1.494 |
| Butalbital-containing Combination Medication | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours | 7.34 scores on a scale | Standard Deviation 1.482 |
| Butalbital-containing Combination Medication | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours | 7.38 scores on a scale | Standard Deviation 1.601 |
| Butalbital-containing Combination Medication | Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | Dose time | 7.30 scores on a scale | Standard Deviation 1.556 |
Secondary
Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing
Participant alertness was evaluated with the 7-point modified SS scale, where 1 is feeling active, vital, alert, wide awake, 2 is still functioning at high levels, but not peak; able to concentrate, 3 is awake, but relaxed; responsive but not fully alert, 4 is somewhat foggy, let down, 5 is foggy, losing interest in remaining awake, 6 is sleepy, woozy, fighting sleep, prefer to lie down, and 7 is no longer fighting sleep, sleep onset soon, having dream like thoughts.
Time frame: Dose time, 2, 4, 6, 8, 24 and 48 hours post-dose. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population. Only participants who responded to the SS scale at a particular time point were included in the analysis for that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours, n=275, 268, 251 | 3.88 units on a scale | Standard Deviation 1.318 |
| Placebo | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours, n=195, 195, 186 | 3.85 units on a scale | Standard Deviation 1.873 |
| Placebo | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours, n=215, 219, 210 | 3.78 units on a scale | Standard Deviation 1.81 |
| Placebo | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | Dose time, n=318, 316, 304 | 3.94 units on a scale | Standard Deviation 1.185 |
| Placebo | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours, n=215, 240, 218 | 2.56 units on a scale | Standard Deviation 1.445 |
| Placebo | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours, n=252, 258, 241 | 2.73 units on a scale | Standard Deviation 1.452 |
| Placebo | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours, n=249, 240, 234 | 3.75 units on a scale | Standard Deviation 1.488 |
| Treximet | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours, n=215, 219, 210 | 3.75 units on a scale | Standard Deviation 1.87 |
| Treximet | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | Dose time, n=318, 316, 304 | 3.97 units on a scale | Standard Deviation 1.156 |
| Treximet | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours, n=275, 268, 251 | 3.87 units on a scale | Standard Deviation 1.481 |
| Treximet | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours, n=249, 240, 234 | 3.67 units on a scale | Standard Deviation 1.718 |
| Treximet | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours, n=195, 195, 186 | 3.81 units on a scale | Standard Deviation 2.061 |
| Treximet | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours, n=252, 258, 241 | 2.80 units on a scale | Standard Deviation 1.516 |
| Treximet | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours, n=215, 240, 218 | 2.72 units on a scale | Standard Deviation 1.453 |
| Butalbital-containing Combination Medication | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours, n=195, 195, 186 | 3.91 units on a scale | Standard Deviation 1.882 |
| Butalbital-containing Combination Medication | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours, n=275, 268, 251 | 3.88 units on a scale | Standard Deviation 1.337 |
| Butalbital-containing Combination Medication | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours, n=215, 240, 218 | 2.60 units on a scale | Standard Deviation 1.522 |
| Butalbital-containing Combination Medication | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours, n=252, 258, 241 | 2.78 units on a scale | Standard Deviation 1.57 |
| Butalbital-containing Combination Medication | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours, n=215, 219, 210 | 3.82 units on a scale | Standard Deviation 1.578 |
| Butalbital-containing Combination Medication | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours, n=249, 240, 234 | 3.91 units on a scale | Standard Deviation 1.555 |
| Butalbital-containing Combination Medication | Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing | Dose time, n=318, 316, 304 | 4.00 units on a scale | Standard Deviation 1.121 |
Secondary
Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1)
Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for the first migraine attack treated. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.
Time frame: From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: Participants in the ITT population who treated migraine Attack 1 with study medication and then used migraine rescue medication after dosing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1) | 12.00 hours | Standard Deviation 1.44 |
| Treximet | Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1) | 17.07 hours | Standard Deviation 1.22 |
| Butalbital-containing Combination Medication | Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1) | 20.15 hours | Standard Deviation 2.07 |
Secondary
Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2)
Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their second migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.
Time frame: From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: Participants in the ITT population who treated migraine Attack 2 with study medication and then used migraine rescue medication after dosing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2) | 8.29 hours | Standard Deviation 1.12 |
| Treximet | Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2) | 20.90 hours | Standard Deviation 1.64 |
| Butalbital-containing Combination Medication | Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2) | 16.70 hours | Standard Deviation 2.05 |
Secondary
Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3)
Average time until participants took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for their third migraine attack treated in the study. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.
Time frame: From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: Participants in the ITT population who treated migraine Attack 3 with study medication and then used migraine rescue medication after dosing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3) | 6.69 hours | Standard Deviation 0.58 |
| Treximet | Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3) | 20.77 hours | Standard Deviation 1.93 |
| Butalbital-containing Combination Medication | Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3) | 9.44 hours | Standard Deviation 1.1 |
Secondary
Number of Participants Using Rescue Medication Within 48 Hours Post Dose
Number of participants who took any medication to treat their migraine pain or symptoms within 48 hours after they took the first dose of study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants were asked not to take rescue for at least 2 hours after they took the study medication (placebo, Treximet, or butalbital-containing combination medication) for that attack. Participants took rescue medication if they felt they needed it.
Time frame: From dose time through 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 1st rescue < 2 hours post-dose | 25 participants |
| Placebo | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 1st rescue (investigational medication) | 234 participants |
| Placebo | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 2nd rescue (investigational medication) | 114 participants |
| Placebo | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of other rescue (not investigational med.) | 6 participants |
| Treximet | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of other rescue (not investigational med.) | 5 participants |
| Treximet | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 1st rescue < 2 hours post-dose | 19 participants |
| Treximet | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 2nd rescue (investigational medication) | 79 participants |
| Treximet | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 1st rescue (investigational medication) | 158 participants |
| Butalbital-containing Combination Medication | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of other rescue (not investigational med.) | 8 participants |
| Butalbital-containing Combination Medication | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 1st rescue (investigational medication) | 203 participants |
| Butalbital-containing Combination Medication | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 2nd rescue (investigational medication) | 121 participants |
| Butalbital-containing Combination Medication | Number of Participants Using Rescue Medication Within 48 Hours Post Dose | Use of 1st rescue < 2 hours post-dose | 25 participants |
Secondary
Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing
Complete symptom-free is defined as migraine-free, neck pain-free, and sinus pain-free without the use of any rescue medication prior to the defined time point.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours | 13 participants |
| Placebo | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours | 19 participants |
| Placebo | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours | 27 participants |
| Placebo | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours | 29 participants |
| Placebo | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours | 43 participants |
| Placebo | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours | 47 participants |
| Treximet | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours | 86 participants |
| Treximet | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours | 29 participants |
| Treximet | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours | 68 participants |
| Treximet | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours | 95 participants |
| Treximet | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours | 68 participants |
| Treximet | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours | 67 participants |
| Butalbital-containing Combination Medication | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 4 hours | 36 participants |
| Butalbital-containing Combination Medication | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 6 hours | 38 participants |
| Butalbital-containing Combination Medication | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 48 hours | 62 participants |
| Butalbital-containing Combination Medication | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 8 hours | 38 participants |
| Butalbital-containing Combination Medication | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 2 hours | 21 participants |
| Butalbital-containing Combination Medication | Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing | 24 hours | 74 participants |
Secondary
Number of Participants With a Migraine-free Response 2-48 Hours After Dosing
Migraine-free is defined as pain-free with no migraine-associated symptoms (nausea, vomiting, photophobia \[sensitivity to light\], and phonophobia \[sensitivity to sound\]) with use of any rescue medication before the defined time point.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 24 hours | 46 participants |
| Placebo | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 6 hours | 28 participants |
| Placebo | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 8 hours | 29 participants |
| Placebo | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 48 hours | 48 participants |
| Placebo | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 4 hours | 20 participants |
| Placebo | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 2 hours | 14 participants |
| Treximet | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 6 hours | 70 participants |
| Treximet | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 2 hours | 33 participants |
| Treximet | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 4 hours | 74 participants |
| Treximet | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 8 hours | 73 participants |
| Treximet | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 24 hours | 101 participants |
| Treximet | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 48 hours | 90 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 4 hours | 37 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 48 hours | 65 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 24 hours | 75 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 6 hours | 39 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 2 hours | 22 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Migraine-free Response 2-48 Hours After Dosing | 8 hours | 40 participants |
Secondary
Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
Pain-Free is defined as having no pain and without the use of any rescue medication from the time of the initial dose of study medication for a particular migraine attack until the defined time point at 2, 4, 6, 8, 24 or 48 hours post-dose.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 2 hours post-dose | 16 participants |
| Placebo | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 4 hours post-dose | 21 participants |
| Placebo | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 6 hours post-dose | 29 participants |
| Placebo | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 8 hours post-dose | 30 participants |
| Placebo | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 24 hours post-dose | 48 participants |
| Placebo | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 48 hours post-dose | 51 participants |
| Treximet | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 48 hours post-dose | 93 participants |
| Treximet | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 2 hours post-dose | 45 participants |
| Treximet | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 8 hours post-dose | 79 participants |
| Treximet | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 24 hours post-dose | 104 participants |
| Treximet | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 4 hours post-dose | 86 participants |
| Treximet | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 6 hours post-dose | 78 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 4 hours post-dose | 39 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 6 hours post-dose | 40 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 48 hours post-dose | 66 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 8 hours post-dose | 42 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 2 hours post-dose | 26 participants |
| Butalbital-containing Combination Medication | Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose | 24 hours post-dose | 78 participants |
Secondary
Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points
The number of participants with no pain and relief of nausea in those participants for whom nausea was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population - including only those participants who reported nausea at dose time.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 5 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 6 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 8 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 9 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 15 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 20 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 41 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 13 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 29 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 39 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 28 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 32 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 8 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 8 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 28 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 9 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 8 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 30 participants |
Secondary
Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points
The number of participants with no pain and relief of phonophobia in those participants for whom phonophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population - including only those participants who reported phonophobia at dose time.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 11 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 15 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 21 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 21 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 33 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 34 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 71 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 25 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 57 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 79 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 57 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 49 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 24 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 30 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 52 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 30 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 15 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 61 participants |
Secondary
Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points
The number of participants with no pain and relief of photophobia in those participants for whom photophobia was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population - including only those participants who reported photophobia at dose time.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 11 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 16 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 22 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 21 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 35 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 38 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 81 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 30 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 61 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 84 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 64 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 54 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 4 hrs post-dose | 23 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 6 hrs post-dose | 27 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 48 hrs post-dose | 20 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 8 hrs post-dose | 32 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 2 hrs post-dose | 16 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points | 24 hrs post-dose | 24 participants |
Secondary
Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose
The number of participants with no pain and relief of vomiting in those participants for whom vomiting was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population - including only those participants who reported vomiting at dose time.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 48 hrs post-dose | 3 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 6 hrs post-dose | 1 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 4 hrs post-dose | 1 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 24 hrs post-dose | 3 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 8 hrs post-dose | 0 participants |
| Placebo | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 2 hrs post-dose | 1 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 4 hrs post-dose | 1 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 48 hrs post-dose | 2 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 2 hrs post-dose | 0 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 24 hrs post-dose | 3 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 6 hrs post-dose | 2 participants |
| Treximet | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 8 hrs post-dose | 1 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 8 hrs post-dose | 1 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 6 hrs post-dose | 1 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 48 hrs post-dose | 2 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 24 hrs post-dose | 3 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 4 hrs post-dose | 0 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose | 2 hrs post-dose | 0 participants |
Secondary
Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain
Pain relief is defined as having no or mild pain and no use of rescue medication after dosing in those participants who had moderate or severe pain at dosing.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population - only participants who reported moderate or severe baseline pain were included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 4 hours post-dose | 51 participants |
| Placebo | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 2 hours post-dose | 76 participants |
| Placebo | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 6 hours post-dose | 48 participants |
| Placebo | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 8 hours post-dose | 46 participants |
| Placebo | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 24 hours post-dose | 62 participants |
| Placebo | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 48 hours post-dose | 54 participants |
| Treximet | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 48 hours post-dose | 99 participants |
| Treximet | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 24 hours post-dose | 127 participants |
| Treximet | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 2 hours post-dose | 148 participants |
| Treximet | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 8 hours post-dose | 97 participants |
| Treximet | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 4 hours post-dose | 124 participants |
| Treximet | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 6 hours post-dose | 107 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 4 hours post-dose | 90 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 6 hours post-dose | 66 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 48 hours post-dose | 71 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 8 hours post-dose | 61 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 2 hours post-dose | 114 participants |
| Butalbital-containing Combination Medication | Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain | 24 hours post-dose | 88 participants |
Secondary
Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline
The number of participants with no pain and relief of neck pain in those participants for whom neck pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population - including only those participants who reported neck pain at dose time.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 2 hrs post-dose | 4 participants |
| Placebo | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 4 hrs post-dose | 7 participants |
| Placebo | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 6 hrs post-dose | 12 participants |
| Placebo | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 8 hrs post-dose | 16 participants |
| Placebo | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 24 hrs post-dose | 20 participants |
| Placebo | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 48 hrs post-dose | 26 participants |
| Treximet | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 48 hrs post-dose | 46 participants |
| Treximet | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 2 hrs post-dose | 19 participants |
| Treximet | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 8 hrs post-dose | 38 participants |
| Treximet | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 24 hrs post-dose | 51 participants |
| Treximet | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 4 hrs post-dose | 43 participants |
| Treximet | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 6 hrs post-dose | 39 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 4 hrs post-dose | 22 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 6 hrs post-dose | 19 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 48 hrs post-dose | 37 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 8 hrs post-dose | 29 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 2 hrs post-dose | 14 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline | 24 hrs post-dose | 44 participants |
Secondary
Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing
The number of participants with no pain and relief of sinus/facial pain in those participants for whom sinus/facial pain was present at dose time. Participants using rescue medication were removed from the participants with relief group for all subsequent timed assessments, regardless of pain and associated symptom evaluations at the specified time point.
Time frame: At 2, 4, 6, 8, 24, and 48 hours post-dose for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population - including only those participants who reported sinus/facial pain at dose time.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 2 hrs post-dose | 5 participants |
| Placebo | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 4 hrs post-dose | 4 participants |
| Placebo | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 6 hrs post-dose | 10 participants |
| Placebo | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 8 hrs post-dose | 8 participants |
| Placebo | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 24 hrs post-dose | 13 participants |
| Placebo | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 48 hrs post-dose | 15 participants |
| Treximet | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 48 hrs post-dose | 40 participants |
| Treximet | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 2 hrs post-dose | 14 participants |
| Treximet | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 8 hrs post-dose | 28 participants |
| Treximet | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 24 hrs post-dose | 38 participants |
| Treximet | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 4 hrs post-dose | 35 participants |
| Treximet | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 6 hrs post-dose | 29 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 4 hrs post-dose | 17 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 6 hrs post-dose | 15 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 48 hrs post-dose | 24 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 8 hrs post-dose | 16 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 2 hrs post-dose | 9 participants |
| Butalbital-containing Combination Medication | Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing | 24 hrs post-dose | 30 participants |
Secondary
Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire)
Clinical disability for each participant was assessed using the CDQ. This scale uses one question to assess ability to perform normal or usual activities. Responses are recorded on a 5-point scale, where 1 is normal/not impaired, 2 is mildly impaired, 3 is moderately impaired, 4 is severely impaired, and 5 is 'required bedrest.
Time frame: At dosing and at 2, 4, 6 and 8 hours after dosing of each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 6 hours | 76 participants |
| Placebo | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 4 hours | 59 participants |
| Placebo | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | At dose time | 9 participants |
| Placebo | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 2 hours | 19 participants |
| Placebo | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 8 hours | 77 participants |
| Treximet | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 4 hours | 62 participants |
| Treximet | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | At dose time | 8 participants |
| Treximet | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 2 hours | 33 participants |
| Treximet | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 6 hours | 77 participants |
| Treximet | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 8 hours | 83 participants |
| Butalbital-containing Combination Medication | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 8 hours | 60 participants |
| Butalbital-containing Combination Medication | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 6 hours | 60 participants |
| Butalbital-containing Combination Medication | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | At dose time | 10 participants |
| Butalbital-containing Combination Medication | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 4 hours | 50 participants |
| Butalbital-containing Combination Medication | Numbers of Participants Able to Engage in Normal Activities Not Impaired at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) | 2 hours | 29 participants |
Secondary
Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication
The PPMQ-R questionnaire was used to assess participant satisfaction with migraine medication; the answers are used to generate a total score and 4 subscales scores for efficacy, functionality, ease-of-use and bothersomeness-of-side effects. The total score was calculated as the average of the efficacy, functionality and ease-of-use subscores. Subscores could range from 0 to 100; higher scores indicate greater satisfaction.
Time frame: At 24 hours after dosing for each attack treated with study medication. All 3 migraine attacks were to have been treated within 19 weeks of randomization (when study medication was dispensed).
Population: ITT Population: those participants who provided any information for the PPMQ-R.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 63 scores on a scale | Standard Error 1.5 |
| Treximet | Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 68 scores on a scale | Standard Error 1.4 |
| Butalbital-containing Combination Medication | Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication | 63 scores on a scale | Standard Error 1.5 |