Workplace Migraine Treatment
Conditions
Keywords
Productivity, Migraine, Treximet, Triptan
Brief summary
Researchers want to learn about work productivity after treatment of a migraine headache with your usual migraine medication as compared to your work productivity after treatment with Treximet. During this research subjects will take Treximet to treat 3 workday migraine attacks. For a second part of the research subjects will take their usual prescribed medication for 3 workday migraine attacks. The subjects will complete questionnaires after treating each migraine.
Detailed description
A subject who is identified for study participation will participate in the screening and enrollment visit which determines the migraine treatment arm to which the subject will be randomized first. The subject will have a physical exam, vital signs recorded, health and medication questions asked, questionnaires completed and a headache diary explained and dispensed to the subject. If the subject is randomized to the Treximet treatment arm during the first part of the study, Treximet will be dispensed for use in treating workday migraines. The subject will call the study coordinator after treating a workday migraine and will report information about the migraine to the coordinator. When the subject has treated and reported on 3 migraines, the interim visit will be scheduled. The subject will bring the study diary and Treximet containers (if this was the arm the subject completed)to this visit. The subject will be asked about adverse events and medication changes as well as confirmation and review of the completed questionnaires and diaries from the prior weeks of study participation. The subject will be given new diaries and questionnaires (and Treximet to use if usual prescribed triptan was the treatment in the first arm) and repeat the activities to treat 3 more workday migraines. When the subject has notified the study coordinator about treating the 3rd workday migraine in this part of the study, the subject will be scheduled for the final study visit. The subject will bring the completed migraine diaries, completed questionnaires (and Treximet bottles if used during this arm) to the study visit. The subject will have the diaries and questionnaires reviewed, be asked about adverse events and medication changes and complete the final study questionnaires at this visit.
Interventions
DRUGTriptan
Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan
DRUGTreximet 85Mg-500Mg Tablet
Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium
Sponsors
GlaxoSmithKline
Currax Pharmaceuticals
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
This was a randomized, open-label, 6-attack (3-attacks per arm) crossover design in which subjects were randomized to threat their first 3 workplace migraines with sumatriptan/naproxen sodium or with their usual triptan monotherapy before treating their subsequent 3 workplace migraines with the opposite medication.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* episodic migraine diagnosis * age 18 or older * currently using a triptan as primary migraine monotherapy * currently employed * if of childbearing potential, willing to prevent pregnancy during study participation * able to understand and consent to study participation
Exclusion criteria
* younger than age 18 * not having episodic migraine diagnosis * not using a triptan as primary migraine monotherapy * not currently employed * pregnant or nursing or unwilling to prevent pregnancy during study participation * unable to understand and consent to study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Workplace Productivity and Activity Impairment Scale (WPAI). | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lost Workplace Productivity | 6 months | 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. |
| Lost Activity Time | 6 Months | 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. |
| Favorable Response on Migraine-ACT | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
This study had no wash-out or run-in phase.
Participants by arm
| Arm | Count |
|---|---|
| All Completed Study 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 | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | All Completed Study Participants |
|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 18 / 45 | 15 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Workplace Productivity and Activity Impairment Scale (WPAI).
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.
Time frame: 6 months
Population: This includes all patients that completed all study visits are included in this efficacy analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 - Triptan | Workplace Productivity and Activity Impairment Scale (WPAI). | 4.15 hours |
| Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm | Workplace Productivity and Activity Impairment Scale (WPAI). | 2.44 hours |
Comparison: Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.p-value: 0.00795% CI: [-2.92, -0.49]Mixed Models Analysis
Secondary
Favorable Response on Migraine-ACT
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 - Triptan | Favorable Response on Migraine-ACT | 46 percentage of favorable responses |
| Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm | Favorable Response on Migraine-ACT | 71 percentage of favorable responses |
Comparison: Logistic regression models with generalized estimating equations were used. In these models, a logit link function was used for a favorable response (yes/no) with treatment as the primary fixed effect and including study period and treatment order as other fixed effects..p-value: 0.01695% CI: [1.22, 6.84]Regression, Logistic
Secondary
Lost Activity Time
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.
Time frame: 6 Months
Population: This includes all patients that completed all study visits are included in this efficacy analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 - Triptan | Lost Activity Time | 1.89 hours |
| Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm | Lost Activity Time | 1.22 hours |
Comparison: Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.p-value: 0.05995% CI: [-1.39, 0.03]Mixed Models Analysis
Secondary
Lost Workplace Productivity
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.
Time frame: 6 months
Population: This includes all patients that completed all study visits are included in this efficacy analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm 1 - Triptan | Lost Workplace Productivity | 2.25 hours |
| Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm | Lost Workplace Productivity | 1.23 hours |
Comparison: Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.p-value: 0.0195% CI: [-1.79, -0.27]Mixed Models Analysis