TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).