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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Currax Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptan | Active Comparator | Arm 1 subjects began with their prescribed triptan |
|
| Treximet 85Mg-500Mg Tablet | Active Comparator | Arm 2 subjects began with Treximet (sumatriptan 85 mg/naproxen sodium 500 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptan | Drug | Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer S Kriegler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, 9500 Euclid Avenue, C-21 | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19486178 | Background | Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27. | |
| 15265257 | Background | Dowson AJ, Tepper SJ, Baos V, Baudet F, D'Amico D, Kilminster S. Identifying patients who require a change in their current acute migraine treatment: the Migraine Assessment of Current Therapy (Migraine-ACT) questionnaire. Curr Med Res Opin. 2004 Jul;20(7):1125-35. doi: 10.1185/030079904125004079. |
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There is no plan to make individual participant data (IPD) available to other researchers.
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This study had no wash-out or run-in phase.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%. |
| FG001 | 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%. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Subjects were lost to follow-up or withdrew consent. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This includes all patients that completed all study visits are included in this efficacy analysis | Posted | Mean | 95% Confidence Interval | hours | 6 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Prescribed Triptan | 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%. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Other | Non-systematic Assessment | Sleepiness |
Unusually high number of subjects lost to follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Kriegler, MD | Cleveland Clinic Foundation | 216-444-8265 | krieglj@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2016 | Nov 16, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2015 | Nov 17, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D018170 | Sumatriptan |
| C000611385 | sumatriptan-naproxen |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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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.
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| Treximet 85Mg-500Mg Tablet | Drug | Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium |
|
|
| 6 months |
| 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. | 6 Months |
| 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. | 6 months |
| 18759540 | Background | Cleves C, Tepper SJ. Sumatriptan/naproxen sodium combination for the treatment of migraine. Expert Rev Neurother. 2008 Sep;8(9):1289-97. doi: 10.1586/14737175.8.9.1289. |
| 17405970 | Background | Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443. |
| NOT COMPLETED |
|
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Not all subjects completed both study arms. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 37 patients completed both phases of the study and make up the primary data set. | Count of Participants | 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 |
| OG001 | Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm | 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 |
|
|
|
| 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. | This includes all patients that completed all study visits are included in this efficacy analysis | Posted | Mean | 95% Confidence Interval | hours | 6 months |
|
|
|
|
| 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. | This includes all patients that completed all study visits are included in this efficacy analysis | Posted | Mean | 95% Confidence Interval | hours | 6 Months |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | percentage of favorable responses | 6 months |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 18 |
| 45 |
| EG001 | Treximet Arm | 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%. | 0 | 45 | 0 | 45 | 15 | 45 |
| Nausea | Gastrointestinal disorders | Other | Non-systematic Assessment |
|
| Lightheadedness | Nervous system disorders | Other | Non-systematic Assessment | Lightheaded, head pressure and tightness and head rush, diaphoresis |
|
| Fatigue | General disorders | Other | Non-systematic Assessment |
|
| Chest Discomfort | General disorders | Other | Non-systematic Assessment |
|
| Giddiness | Nervous system disorders | Other | Non-systematic Assessment | Loopiness and Dopey |
|
| Apraxia | Nervous system disorders | Other | Non-systematic Assessment | Word finding difficulty |
|
| Bladder pain | Renal and urinary disorders | Other | Non-systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | Other | Non-systematic Assessment |
|
| Irritability | General disorders | Other | Non-systematic Assessment |
|
| Xerostomia | General disorders | Other | Non-systematic Assessment | dry mouth and jaw tightness |
|
| Paresthesia | Nervous system disorders | Other | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |