Trial Outcomes & Findings for Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? (NCT NCT01086358)

Last Updated: 2018-05-01

Results Overview

The primary outcome measure was lost productivity (workplace productivity + non-workplace activity time) as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

6 months

Results posted on

2018-05-01

Participant Flow

60 Subjects who are employed in a paying job, who have episodic migraine (\<15 days/month), who are using an acute care triptan monotherapy for their migraine (excluding combinations of any sort, such as acetaminophen \[APAP\] and non-steoridals \[NSAIDs\]) and who have no contraindications to triptan or NSAID use.

This study had no wash-out or run-in phase.

Participant milestones

Participant milestones
Measure	Usual Prescribed Triptan First Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 60, with 30 in each sequence, would power the study at 86%.	Treximet Arm First Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.
First Intervention STARTED	30	29
First Intervention COMPLETED	21	24
First Intervention NOT COMPLETED	9	5
Second Intervention STARTED	21	24
Second Intervention COMPLETED	17	20
Second Intervention NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Prescribed Triptan First Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 60, with 30 in each sequence, would power the study at 86%.	Treximet Arm First Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.
First Intervention Lost to Follow-up	9	4
First Intervention Withdrawal by Subject	0	1
Second Intervention Lost to Follow-up	4	4

Baseline Characteristics

Subjects were lost to follow-up or withdrew consent.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Completed Study Participants n=37 Participants Participants received their usual prescribed triptan or Treximet, depending on the randomization schedule. Usual prescribed triptan: usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan
Age, Continuous	41.4 years STANDARD_DEVIATION 9.4 • n=5 Participants • Subjects were lost to follow-up or withdrew consent.
Sex: Female, Male Female	33 Participants n=5 Participants • Not all subjects completed both study arms.
Sex: Female, Male Male	4 Participants n=5 Participants • Not all subjects completed both study arms.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • 37 patients completed both phases of the study and make up the primary data set.
Race (NIH/OMB) Asian	0 Participants n=5 Participants • 37 patients completed both phases of the study and make up the primary data set.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • 37 patients completed both phases of the study and make up the primary data set.
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants • 37 patients completed both phases of the study and make up the primary data set.
Race (NIH/OMB) White	34 Participants n=5 Participants • 37 patients completed both phases of the study and make up the primary data set.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • 37 patients completed both phases of the study and make up the primary data set.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • 37 patients completed both phases of the study and make up the primary data set.

PRIMARY outcome

Timeframe: 6 months

Population: This includes all patients that completed all study visits are included in this efficacy analysis

Outcome measures

Outcome measures
Measure	Arm 1 - Triptan n=37 Participants Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan	Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm n=37 Participants Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg
Workplace Productivity and Activity Impairment Scale (WPAI).	4.15 hours Interval 2.93 to 5.36	2.44 hours Interval 1.23 to 3.65

SECONDARY outcome

Timeframe: 6 months

Population: This includes all patients that completed all study visits are included in this efficacy analysis

This outcome measure was lost workplace productivity as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.

Outcome measures

Outcome measures
Measure	Arm 1 - Triptan n=37 Participants Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan	Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm n=37 Participants Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg
Lost Workplace Productivity	2.25 hours Interval 1.6 to 2.9	1.23 hours Interval 0.58 to 1.87

SECONDARY outcome

Timeframe: 6 Months

Population: This includes all patients that completed all study visits are included in this efficacy analysis

This outcome measure was lost activity time as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.

Outcome measures

Outcome measures
Measure	Arm 1 - Triptan n=37 Participants Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan	Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm n=37 Participants Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg
Lost Activity Time	1.89 hours Interval 1.19 to 2.6	1.22 hours Interval 0.51 to 1.92

SECONDARY outcome

Timeframe: 6 months

The Migraine-ACT is a 4-item scale with yes/no responses. A score of 3 or more is considered favorable. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The Migraine-ACT is reported as a binary measure (3 or more positive responses). The outcome presented included the percentage with a score of 3 or more, and the Odds ratio comparing the two treatments.

Outcome measures

Outcome measures
Measure	Arm 1 - Triptan n=37 Participants Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Arm 1 Triptan: Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan	Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm n=37 Participants Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Arm 2 - Sumatriptan/naproxen sodium (Treximet): Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg
Favorable Response on Migraine-ACT	46 percentage of favorable responses Interval 30.0 to 63.0	71 percentage of favorable responses Interval 54.0 to 84.0

Adverse Events

Usual Prescribed Triptan

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Treximet Arm

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Usual Prescribed Triptan n=45 participants at risk Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.	Treximet Arm n=45 participants at risk Subjects will be randomized to either of two arms at enrollment in this study. They may start with their usual prescribed triptan or Treximet, depending on the randomization schedule. Treximet for migraine treatment: Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg. To account for the correlation from patients acting as their own controls in this crossover design, a standard deviation of the difference equal to 2.5 is assumed. Under these assumptions, a total sample of 760, with 30 in each sequence, would power the study at 86%.
Nervous system disorders Somnolence	17.8% 8/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	8.9% 4/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
Gastrointestinal disorders Nausea	11.1% 5/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	13.3% 6/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
Nervous system disorders Lightheadedness	8.9% 4/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
General disorders Fatigue	8.9% 4/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
General disorders Chest Discomfort	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
Nervous system disorders Giddiness	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
Nervous system disorders Apraxia	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
Renal and urinary disorders Bladder pain	0.00% 0/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
Musculoskeletal and connective tissue disorders Muscle weakness	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	0.00% 0/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
General disorders Irritability	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	0.00% 0/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
General disorders Xerostomia	4.4% 2/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	0.00% 0/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.
Nervous system disorders Paresthesia	2.2% 1/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.	0.00% 0/45 • Approximately 6 months Adverse events were noted from the date of the first study visit until the end of study visit was completed, grouped by the treatment medication in use. There were no serious AEs. 45 patients entered the Triptan arm and 45 patients entered the Treximet arm. 12 patients failed to report AE status and were considered to be free from AEs in the calculations below.

Additional Information

Jennifer Kriegler, MD

Cleveland Clinic Foundation

Phone: 216-444-8265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place