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

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ClinicalTrials.gov Identifier: NCT00573170
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : December 29, 2010
Last Update Posted : December 29, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Migraine Disorders
Migraine, Acute
Interventions Drug: TREXIMET®
Drug: Butalbital-containing Combination Medications (BCM)
Drug: placebo
Enrollment 375
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
Arm/Group Title Treximet, Placebo, Butalbital-containing Combo. Medication Treximet, Butalbital-containing Combo. Medication, Placebo Butalbital-containing Combo. Medication, Treximet, Placebo Butalbital-containing Combo. Medication, Placebo, Treximet Placebo, Treximet, Butalbital-containing Combo. Medication Placebo, Butalbital-containing Combo. Medication, Treximet
Hide Arm/Group Description Fixed dose combination (combo.) tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated. Fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated. Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated. Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated. Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated. Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
Period Title: First Treatment Period
Started 64 60 60 66 63 62
Completed 64 60 60 66 62 62
Not Completed 0 0 0 0 1 0
Reason Not Completed
Did Not Treat Attack 1             0             0             0             0             1             0
Period Title: First Washout Period
Started 64 60 60 66 62 62
Completed 56 58 59 61 59 [1] 55
Not Completed 8 2 1 5 3 7
Reason Not Completed
Adverse Event             1             1             0             0             0             1
Lack of Efficacy             0             0             0             0             0             1
Lost to Follow-up             1             1             0             2             0             2
Withdrawal by Subject             2             0             0             2             3             3
Other             4             0             1             1             0             0
[1]
Source data list 4 noncompleters; per number starting next period, there were only 3 noncompleters.
Period Title: Second Treatment Period
Started 56 58 59 61 59 55
Completed 56 58 59 61 59 55
Not Completed 0 0 0 0 0 0
Period Title: Second Washout Period
Started 56 58 59 61 59 55
Completed 51 54 55 56 51 53
Not Completed 5 4 4 5 8 2
Reason Not Completed
Adverse Event             1             0             0             0             1             0
Protocol Violation             2             1             1             0             0             0
Withdrawal by Subject             1             1             2             0             1             0
Lost to Follow-up             0             0             0             1             0             0
Other             1             2             1             4             6             2
Period Title: Third Treatment Period
Started 51 54 55 56 51 53
Completed 50 54 55 56 51 51
Not Completed 1 0 0 0 0 2
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             2
Arm/Group Title All Study Participants Treated at Least Once
Hide Arm/Group Description All study participants who were treated at least once with study medication
Overall Number of Baseline Participants 442
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 442 participants
42.6  (11.23)
[1]
Measure Description: Baseline data are reported for the Safety Population, comprised of all participants who were treated at least once with study medication. . All randomized participants are accounted for in the Participant Flow module. Only a portion of the participants who were randomized comprise the Safety Population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 442 participants
Female
391
  88.5%
Male
51
  11.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 442 participants
White-White/Caucasian/European Heritage 368
African American/African Heritage 61
Mixed Race 4
Asian - Central/South 2
Asian - South East Asian Heritage 2
White - Arabic/North African Heritage 2
American Indian or Native Alaskan 1
Asian - Japanese Heritage 1
Native Hawaiian or Other Pacific Islander 1
1.Primary Outcome
Title Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 320 317 304
Measure Type: Number
Unit of Measure: participants
10 26 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treximet, Butalbital-containing Combination Medication
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378
Comments Compares odds ratio.
Method Generalized Estimating Equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.7 to 2.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 320 317 304
Measure Type: Number
Unit of Measure: participants
2 hours post-dose 16 45 26
4 hours post-dose 21 86 39
6 hours post-dose 29 78 40
8 hours post-dose 30 79 42
24 hours post-dose 48 104 78
48 hours post-dose 51 93 66
3.Secondary Outcome
Title Number of Participants Using Rescue Medication Within 48 Hours Post Dose
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 320 317 304
Measure Type: Number
Unit of Measure: participants
Use of 1st rescue < 2 hours post-dose 25 19 25
Use of 1st rescue (investigational medication) 234 158 203
Use of 2nd rescue (investigational medication) 114 79 121
Use of other rescue (not investigational med.) 6 5 8
4.Secondary Outcome
Title Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1)
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who treated migraine Attack 1 with study medication and then used migraine rescue medication after dosing.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with placebo
Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Treximet
Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Butalbital-containing combination medication
Overall Number of Participants Analyzed 74 52 67
Mean (Standard Deviation)
Unit of Measure: hours
12.00  (1.44) 17.07  (1.22) 20.15  (2.07)
5.Secondary Outcome
Title Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2)
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who treated migraine Attack 2 with study medication and then used migraine rescue medication after dosing.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with placebo
Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Treximet
Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Butalbital-containing combination medication
Overall Number of Participants Analyzed 90 55 72
Mean (Standard Deviation)
Unit of Measure: hours
8.29  (1.12) 20.90  (1.64) 16.70  (2.05)
6.Secondary Outcome
Title Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3)
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT population who treated migraine Attack 3 with study medication and then used migraine rescue medication after dosing.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with placebo
Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Treximet
Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Butalbital-containing combination medication
Overall Number of Participants Analyzed 72 58 65
Mean (Standard Deviation)
Unit of Measure: hours
6.69  (0.58) 20.77  (1.93) 9.44  (1.10)
7.Secondary Outcome
Title Number of Participants With a Migraine-free Response 2-48 Hours After Dosing
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 320 317 304
Measure Type: Number
Unit of Measure: participants
2 hours 14 33 22
4 hours 20 74 37
6 hours 28 70 39
8 hours 29 73 40
24 hours 46 101 75
48 hours 48 90 65
8.Secondary Outcome
Title Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - including only those participants who reported nausea at dose time.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 152 154 133
Measure Type: Number
Unit of Measure: participants
2 hrs post-dose 5 13 8
4 hrs post-dose 6 28 8
6 hrs post-dose 8 32 8
8 hrs post-dose 9 29 9
24 hrs post-dose 15 39 30
48 hrs post-dose 20 41 28
9.Secondary Outcome
Title Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - including only those participants who reported photophobia at dose time.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 277 269 251
Measure Type: Number
Unit of Measure: participants
2 hrs post-dose 11 30 16
4 hrs post-dose 16 64 23
6 hrs post-dose 22 54 27
8 hrs post-dose 21 61 32
24 hrs post-dose 35 84 24
48 hrs post-dose 38 81 20
10.Secondary Outcome
Title Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - including only those participants who reported phonophobia at dose time.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 257 246 211
Measure Type: Number
Unit of Measure: participants
2 hrs post-dose 11 25 15
4 hrs post-dose 15 57 24
6 hrs post-dose 21 49 30
8 hrs post-dose 21 57 30
24 hrs post-dose 33 79 61
48 hrs post-dose 34 71 52
11.Secondary Outcome
Title Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - including only those participants who reported vomiting at dose time.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 17 22 16
Measure Type: Number
Unit of Measure: participants
2 hrs post-dose 1 0 0
4 hrs post-dose 1 1 0
6 hrs post-dose 1 2 1
8 hrs post-dose 0 1 1
24 hrs post-dose 3 3 3
48 hrs post-dose 3 2 2
12.Secondary Outcome
Title 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
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - including only those participants who reported sinus/facial pain at dose time.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 133 148 134
Measure Type: Number
Unit of Measure: participants
2 hrs post-dose 5 14 9
4 hrs post-dose 4 35 17
6 hrs post-dose 10 29 15
8 hrs post-dose 8 28 16
24 hrs post-dose 13 38 30
48 hrs post-dose 15 40 24
13.Secondary Outcome
Title 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
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - including only those participants who reported neck pain at dose time.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 194 181 188
Measure Type: Number
Unit of Measure: participants
2 hrs post-dose 4 19 14
4 hrs post-dose 7 43 22
6 hrs post-dose 12 39 19
8 hrs post-dose 16 38 29
24 hrs post-dose 20 51 44
48 hrs post-dose 26 46 37
14.Secondary Outcome
Title Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - only participants who reported moderate or severe baseline pain were included in this analysis.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 309 307 296
Measure Type: Number
Unit of Measure: participants
2 hours post-dose 76 148 114
4 hours post-dose 51 124 90
6 hours post-dose 48 107 66
8 hours post-dose 46 97 61
24 hours post-dose 62 127 88
48 hours post-dose 54 99 71
15.Secondary Outcome
Title Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 320 317 304
Measure Type: Number
Unit of Measure: participants
2 hours 13 29 21
4 hours 19 68 36
6 hours 27 67 38
8 hours 29 68 38
24 hours 43 95 74
48 hours 47 86 62
16.Secondary Outcome
Title Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 320 317 304
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Dose time 7.36  (1.598) 7.29  (1.534) 7.30  (1.556)
2 hours 7.33  (1.606) 7.37  (1.568) 7.27  (1.579)
4 hours 7.44  (1.568) 7.50  (1.576) 7.38  (1.601)
6 hours 7.38  (1.658) 7.43  (1.532) 7.34  (1.482)
8 hours 7.45  (1.666) 7.33  (1.632) 7.33  (1.538)
24 hours 7.66  (1.524) 7.82  (1.525) 7.61  (1.494)
48 hours 7.78  (1.636) 7.88  (1.351) 7.69  (1.463)
17.Secondary Outcome
Title Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing
Hide Description 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).
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Hide Analysis Population Description
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/Group Title Placebo Treximet Butalbital-containing Combination Medication
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Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 318 316 304
Mean (Standard Deviation)
Unit of Measure: units on a scale
Dose time, n=318, 316, 304 3.94  (1.185) 3.97  (1.156) 4.00  (1.121)
2 hours, n=275, 268, 251 3.88  (1.318) 3.87  (1.481) 3.88  (1.337)
4 hours, n=249, 240, 234 3.75  (1.488) 3.67  (1.718) 3.91  (1.555)
6 hours, n=215, 219, 210 3.78  (1.810) 3.75  (1.870) 3.82  (1.578)
8 hours, n=195, 195, 186 3.85  (1.873) 3.81  (2.061) 3.91  (1.882)
24 hours, n=252, 258, 241 2.73  (1.452) 2.80  (1.516) 2.78  (1.570)
48 hours, n=215, 240, 218 2.56  (1.445) 2.72  (1.453) 2.60  (1.522)
18.Secondary Outcome
Title Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine
Hide Description 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).
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Hide Analysis Population Description
ITT Population: those participants who provided any information for the PPMQ-R.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 224 254 234
Mean (Standard Error)
Unit of Measure: scores on a scale
55  (1.8) 62  (1.7) 56  (1.8)
19.Secondary Outcome
Title Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication
Hide Description 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).
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Hide Analysis Population Description
ITT Population: those participants who provided any information for the PPMQ-R.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 224 254 234
Mean (Standard Error)
Unit of Measure: scores on a scale
55  (1.9) 61  (1.8) 56  (1.9)
20.Secondary Outcome
Title Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: those participants who provided any information for the PPMQ-R.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 224 254 234
Mean (Standard Error)
Unit of Measure: scores on a scale
79  (1.3) 82  (1.3) 78  (1.3)
21.Secondary Outcome
Title Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: those participants who provided any information for the PPMQ-R.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 224 254 234
Mean (Standard Error)
Unit of Measure: scores on a scale
88  (0.8) 86  (0.8) 89  (0.9)
22.Secondary Outcome
Title Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: those participants who provided any information for the PPMQ-R.
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 224 254 234
Mean (Standard Error)
Unit of Measure: scores on a scale
63  (1.5) 68  (1.4) 63  (1.5)
23.Secondary Outcome
Title 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)
Hide Description 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).
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Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description:
Attacks for which treatment of moderate or severe pain was placebo
Attacks for which treatment of moderate or severe pain was Treximet
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
Overall Number of Participants Analyzed 320 317 304
Measure Type: Number
Unit of Measure: participants
At dose time 9 8 10
2 hours 19 33 29
4 hours 59 62 50
6 hours 76 77 60
8 hours 77 83 60
Time Frame Adverse events (AEs) were collected from the time of first dose of study medication until the final study visit (within 19 weeks of randomization). Serious AEs were also collected if they occurred prior to dosing and were related to screening procedures.
Adverse Event Reporting Description AEs and SAEs were assessed in the Safety Population (SP), comprised of all 442 participants treated at least once with study medication. Only a portion of the participants who were randomized comprise the SP. Reflecting the study’s cross over design, AEs are categorized by the initial blinded treatment for the attack treated preceding AE onset.
 
Arm/Group Title Placebo Treximet Butalbital-containing Combination Medication
Hide Arm/Group Description Participants who reported an SAE anytime after initial treatment with blinded placebo, but before another initial treatment with any other investigational product Participants who reported an SAE anytime after initial treatment with blinded Treximet, but before another initial treatment with any other investigational product Participants who reported an SAE anytime after initial treatment with blinded Butalbital-containing combination medication, but before another initial treatment with any other investigational product
All-Cause Mortality
Placebo Treximet Butalbital-containing Combination Medication
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Treximet Butalbital-containing Combination Medication
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/405 (0.25%)   2/406 (0.49%)   0/392 (0.00%) 
General disorders       
Chest pain  1  0/405 (0.00%)  1/406 (0.25%)  0/392 (0.00%) 
Infections and infestations       
Meningitis viral  1  1/405 (0.25%)  0/406 (0.00%)  0/392 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  0/405 (0.00%)  1/406 (0.25%)  0/392 (0.00%) 
Colon neoplasm  1  1/405 (0.25%)  0/406 (0.00%)  0/392 (0.00%) 
Vascular disorders       
Hypertension  1  0/405 (0.00%)  1/406 (0.25%)  0/392 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, v12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Treximet Butalbital-containing Combination Medication
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/405 (1.98%)   8/406 (1.97%)   2/392 (0.51%) 
Gastrointestinal disorders       
Nausea  1  8/405 (1.98%)  8/406 (1.97%)  2/392 (0.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, v12.0
Enrolled participants included all those entering the screening part of the study. Randomized participants included only those who completed screening and completed the 2-week butalbital wash-out, and were successfully randomized to study drug.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00573170     History of Changes
Obsolete Identifiers: NCT00599157, NCT01812408
Other Study ID Numbers: TRX109011/TRX109013
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: August 16, 2010
Results First Posted: December 29, 2010
Last Update Posted: December 29, 2010