Clinical trial NCT01086358: Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
Official title: A Single Center Randomized Open-Label Two Arm Crossover Study of Subject Productivity Improvement and Satisfaction With Migraine Treatment Using Treximet vs Usual Triptan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Workplace Migraine Treatment
Keywords: Productivity
Migraine
Treximet
Triptan
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Currax Pharmaceuticals
First posted: 2010-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Workplace Productivity and Activity Impairment Scale (WPAI).
timeFrame: 6 months
Secondary outcomes:
measure: Lost Workplace Productivity
timeFrame: 6 months
measure: Lost Activity Time
timeFrame: 6 Months
measure: Favorable Response on Migraine-ACT
timeFrame: 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, 9500 Euclid Avenue, C-21
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jennifer S Kriegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.