Trial Outcomes & Findings for TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults (NCT NCT00573170)
NCT ID: NCT00573170
Last Updated: 2010-12-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
375 participants
Primary outcome timeframe
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).
Results posted on
2010-12-29
Participant Flow
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.
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
Participant milestones
| Measure |
Treximet, Placebo, Butalbital-containing Combo. Medication
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.
|
Treximet, Butalbital-containing Combo. Medication, Placebo
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.
|
Butalbital-containing Combo. Medication, Treximet, Placebo
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.
|
Butalbital-containing Combo. Medication, Placebo, Treximet
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.
|
Placebo, Treximet, Butalbital-containing Combo. Medication
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.
|
Placebo, Butalbital-containing Combo. Medication, Treximet
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.
|
|---|---|---|---|---|---|---|
|
First Treatment Period
STARTED
|
64
|
60
|
60
|
66
|
63
|
62
|
|
First Treatment Period
COMPLETED
|
64
|
60
|
60
|
66
|
62
|
62
|
|
First Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
First Washout Period
STARTED
|
64
|
60
|
60
|
66
|
62
|
62
|
|
First Washout Period
COMPLETED
|
56
|
58
|
59
|
61
|
59
|
55
|
|
First Washout Period
NOT COMPLETED
|
8
|
2
|
1
|
5
|
3
|
7
|
|
Second Treatment Period
STARTED
|
56
|
58
|
59
|
61
|
59
|
55
|
|
Second Treatment Period
COMPLETED
|
56
|
58
|
59
|
61
|
59
|
55
|
|
Second Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Washout Period
STARTED
|
56
|
58
|
59
|
61
|
59
|
55
|
|
Second Washout Period
COMPLETED
|
51
|
54
|
55
|
56
|
51
|
53
|
|
Second Washout Period
NOT COMPLETED
|
5
|
4
|
4
|
5
|
8
|
2
|
|
Third Treatment Period
STARTED
|
51
|
54
|
55
|
56
|
51
|
53
|
|
Third Treatment Period
COMPLETED
|
50
|
54
|
55
|
56
|
51
|
51
|
|
Third Treatment Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Treximet, Placebo, Butalbital-containing Combo. Medication
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.
|
Treximet, Butalbital-containing Combo. Medication, Placebo
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.
|
Butalbital-containing Combo. Medication, Treximet, Placebo
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.
|
Butalbital-containing Combo. Medication, Placebo, Treximet
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.
|
Placebo, Treximet, Butalbital-containing Combo. Medication
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.
|
Placebo, Butalbital-containing Combo. Medication, Treximet
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.
|
|---|---|---|---|---|---|---|
|
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
Withdrawal by Subject
|
2
|
0
|
0
|
2
|
3
|
3
|
|
First Washout Period
Other
|
4
|
0
|
1
|
1
|
0
|
0
|
|
Second Washout Period
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Second Washout Period
Protocol Violation
|
2
|
1
|
1
|
0
|
0
|
0
|
|
Second Washout Period
Withdrawal by Subject
|
1
|
1
|
2
|
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
|
|
Third Treatment Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Third Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
Baseline characteristics by cohort
| Measure |
All Study Participants Treated at Least Once
n=442 Participants
All study participants who were treated at least once with study medication
|
|---|---|
|
Age Continuous
|
42.6 Years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
391 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
368 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
61 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Native Alaskan
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=320 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=317 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=304 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose
|
10 participants
|
26 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Placebo
n=320 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=317 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=304 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
2 hours post-dose
|
16 participants
|
45 participants
|
26 participants
|
|
Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
4 hours post-dose
|
21 participants
|
86 participants
|
39 participants
|
|
Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
6 hours post-dose
|
29 participants
|
78 participants
|
40 participants
|
|
Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
8 hours post-dose
|
30 participants
|
79 participants
|
42 participants
|
|
Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
24 hours post-dose
|
48 participants
|
104 participants
|
78 participants
|
|
Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose
48 hours post-dose
|
51 participants
|
93 participants
|
66 participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Placebo
n=320 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=317 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=304 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
Number of Participants Using Rescue Medication Within 48 Hours Post Dose
Use of other rescue (not investigational med.)
|
6 participants
|
5 participants
|
8 participants
|
|
Number of Participants Using Rescue Medication Within 48 Hours Post Dose
Use of 1st rescue < 2 hours post-dose
|
25 participants
|
19 participants
|
25 participants
|
|
Number of Participants Using Rescue Medication Within 48 Hours Post Dose
Use of 1st rescue (investigational medication)
|
234 participants
|
158 participants
|
203 participants
|
|
Number of Participants Using Rescue Medication Within 48 Hours Post Dose
Use of 2nd rescue (investigational medication)
|
114 participants
|
79 participants
|
121 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=74 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=52 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=67 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
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
|
17.07 hours
Standard Deviation 1.22
|
20.15 hours
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=90 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=55 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=72 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
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
|
20.90 hours
Standard Deviation 1.64
|
16.70 hours
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=72 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=58 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=65 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
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
|
20.77 hours
Standard Deviation 1.93
|
9.44 hours
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Placebo
n=320 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=317 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=304 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
Number of Participants With a Migraine-free Response 2-48 Hours After Dosing
2 hours
|
14 participants
|
33 participants
|
22 participants
|
|
Number of Participants With a Migraine-free Response 2-48 Hours After Dosing
6 hours
|
28 participants
|
70 participants
|
39 participants
|
|
Number of Participants With a Migraine-free Response 2-48 Hours After Dosing
8 hours
|
29 participants
|
73 participants
|
40 participants
|
|
Number of Participants With a Migraine-free Response 2-48 Hours After Dosing
24 hours
|
46 participants
|
101 participants
|
75 participants
|
|
Number of Participants With a Migraine-free Response 2-48 Hours After Dosing
48 hours
|
48 participants
|
90 participants
|
65 participants
|
|
Number of Participants With a Migraine-free Response 2-48 Hours After Dosing
4 hours
|
20 participants
|
74 participants
|
37 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=152 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=154 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=133 Participants
Attacks for which treatment of moderate or severe pain was 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
|
5 participants
|
13 participants
|
8 participants
|
|
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
|
28 participants
|
8 participants
|
|
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
|
39 participants
|
30 participants
|
|
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
|
41 participants
|
28 participants
|
|
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
|
32 participants
|
8 participants
|
|
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
|
29 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=277 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=269 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=251 Participants
Attacks for which treatment of moderate or severe pain was 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
|
11 participants
|
30 participants
|
16 participants
|
|
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
|
84 participants
|
24 participants
|
|
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
|
81 participants
|
20 participants
|
|
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
|
64 participants
|
23 participants
|
|
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
|
54 participants
|
27 participants
|
|
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
|
61 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=257 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=246 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=211 Participants
Attacks for which treatment of moderate or severe pain was 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
|
34 participants
|
71 participants
|
52 participants
|
|
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
|
25 participants
|
15 participants
|
|
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
|
57 participants
|
24 participants
|
|
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
|
49 participants
|
30 participants
|
|
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
|
57 participants
|
30 participants
|
|
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
|
79 participants
|
61 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=22 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=16 Participants
Attacks for which treatment of moderate or severe pain was 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
|
1 participants
|
0 participants
|
0 participants
|
|
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
|
1 participants
|
0 participants
|
|
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
|
2 participants
|
1 participants
|
|
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
|
1 participants
|
1 participants
|
|
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
|
3 participants
|
3 participants
|
|
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
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=133 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=148 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=134 Participants
Attacks for which treatment of moderate or severe pain was 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
|
5 participants
|
14 participants
|
9 participants
|
|
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
|
35 participants
|
17 participants
|
|
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
|
29 participants
|
15 participants
|
|
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
|
28 participants
|
16 participants
|
|
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
|
38 participants
|
30 participants
|
|
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
|
40 participants
|
24 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=194 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=181 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=188 Participants
Attacks for which treatment of moderate or severe pain was 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
|
16 participants
|
38 participants
|
29 participants
|
|
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
|
19 participants
|
14 participants
|
|
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
|
43 participants
|
22 participants
|
|
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
|
39 participants
|
19 participants
|
|
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
|
51 participants
|
44 participants
|
|
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
|
46 participants
|
37 participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=309 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=307 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=296 Participants
Attacks for which treatment of moderate or severe pain was 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
|
76 participants
|
148 participants
|
114 participants
|
|
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
|
124 participants
|
90 participants
|
|
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
|
107 participants
|
66 participants
|
|
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
|
97 participants
|
61 participants
|
|
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
|
127 participants
|
88 participants
|
|
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
|
99 participants
|
71 participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Placebo
n=320 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=317 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=304 Participants
Attacks for which treatment of moderate or severe pain was 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
|
43 participants
|
95 participants
|
74 participants
|
|
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
|
86 participants
|
62 participants
|
|
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
|
29 participants
|
21 participants
|
|
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
|
68 participants
|
36 participants
|
|
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
|
67 participants
|
38 participants
|
|
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
|
68 participants
|
38 participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Placebo
n=320 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=317 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=304 Participants
Attacks for which treatment of moderate or severe pain was 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
|
7.44 scores on a scale
Standard Deviation 1.568
|
7.50 scores on a scale
Standard Deviation 1.576
|
7.38 scores on a scale
Standard Deviation 1.601
|
|
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
|
7.29 scores on a scale
Standard Deviation 1.534
|
7.30 scores on a scale
Standard Deviation 1.556
|
|
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
|
7.37 scores on a scale
Standard Deviation 1.568
|
7.27 scores on a scale
Standard Deviation 1.579
|
|
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
|
7.43 scores on a scale
Standard Deviation 1.532
|
7.34 scores on a scale
Standard Deviation 1.482
|
|
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
|
7.33 scores on a scale
Standard Deviation 1.632
|
7.33 scores on a scale
Standard Deviation 1.538
|
|
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
|
7.82 scores on a scale
Standard Deviation 1.525
|
7.61 scores on a scale
Standard Deviation 1.494
|
|
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
|
7.88 scores on a scale
Standard Deviation 1.351
|
7.69 scores on a scale
Standard Deviation 1.463
|
SECONDARY outcome
Timeframe: 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.
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".
Outcome measures
| Measure |
Placebo
n=318 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=316 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=304 Participants
Attacks for which treatment of moderate or severe pain was 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
|
3.94 units on a scale
Standard Deviation 1.185
|
3.97 units on a scale
Standard Deviation 1.156
|
4.00 units on a scale
Standard Deviation 1.121
|
|
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
|
3.87 units on a scale
Standard Deviation 1.481
|
3.88 units on a scale
Standard Deviation 1.337
|
|
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
|
3.67 units on a scale
Standard Deviation 1.718
|
3.91 units on a scale
Standard Deviation 1.555
|
|
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 1.810
|
3.75 units on a scale
Standard Deviation 1.870
|
3.82 units on a scale
Standard Deviation 1.578
|
|
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
|
3.81 units on a scale
Standard Deviation 2.061
|
3.91 units on a scale
Standard Deviation 1.882
|
|
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
|
2.80 units on a scale
Standard Deviation 1.516
|
2.78 units on a scale
Standard Deviation 1.570
|
|
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
|
2.72 units on a scale
Standard Deviation 1.453
|
2.60 units on a scale
Standard Deviation 1.522
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=224 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=254 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=234 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
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
|
62 scores on a scale
Standard Error 1.7
|
56 scores on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=224 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=254 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=234 Participants
Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
|
|---|---|---|---|
|
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
|
61 scores on a scale
Standard Error 1.8
|
56 scores on a scale
Standard Error 1.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=224 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=254 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=234 Participants
Attacks for which treatment of moderate or severe pain was 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
|
79 scores on a scale
Standard Error 1.3
|
82 scores on a scale
Standard Error 1.3
|
78 scores on a scale
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=224 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=254 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=234 Participants
Attacks for which treatment of moderate or severe pain was 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
|
88 scores on a scale
Standard Error 0.8
|
86 scores on a scale
Standard Error 0.8
|
89 scores on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=224 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=254 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=234 Participants
Attacks for which treatment of moderate or severe pain was 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
|
68 scores on a scale
Standard Error 1.4
|
63 scores on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: 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
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".
Outcome measures
| Measure |
Placebo
n=320 Participants
Attacks for which treatment of moderate or severe pain was placebo
|
Treximet
n=317 Participants
Attacks for which treatment of moderate or severe pain was Treximet
|
Butalbital-containing Combination Medication
n=304 Participants
Attacks for which treatment of moderate or severe pain was 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
|
9 participants
|
8 participants
|
10 participants
|
|
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
|
33 participants
|
29 participants
|
|
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
|
62 participants
|
50 participants
|
|
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
|
77 participants
|
60 participants
|
|
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
|
83 participants
|
60 participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Treximet
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Butalbital-containing Combination Medication
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=405 participants at risk
Participants who reported an SAE anytime after initial treatment with blinded placebo, but before another initial treatment with any other investigational product
|
Treximet
n=406 participants at risk
Participants who reported an SAE anytime after initial treatment with blinded Treximet, but before another initial treatment with any other investigational product
|
Butalbital-containing Combination Medication
n=392 participants at risk
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
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/405 • 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.
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.
|
0.25%
1/406 • 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.
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.
|
0.00%
0/392 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.25%
1/405 • 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.
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.
|
0.00%
0/406 • 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.
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.
|
0.00%
0/392 • 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.
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.
|
|
General disorders
Chest pain
|
0.00%
0/405 • 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.
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.
|
0.25%
1/406 • 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.
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.
|
0.00%
0/392 • 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.
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.
|
|
Infections and infestations
Meningitis viral
|
0.25%
1/405 • 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.
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.
|
0.00%
0/406 • 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.
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.
|
0.00%
0/392 • 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.
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/405 • 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.
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.
|
0.25%
1/406 • 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.
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.
|
0.00%
0/392 • 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.
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.
|
Other adverse events
| Measure |
Placebo
n=405 participants at risk
Participants who reported an SAE anytime after initial treatment with blinded placebo, but before another initial treatment with any other investigational product
|
Treximet
n=406 participants at risk
Participants who reported an SAE anytime after initial treatment with blinded Treximet, but before another initial treatment with any other investigational product
|
Butalbital-containing Combination Medication
n=392 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.0%
8/405 • 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.
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.
|
2.0%
8/406 • 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.
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.
|
0.51%
2/392 • 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.
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER