Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? - Full Text View

Sponsor:	The Cleveland Clinic
Collaborator:	GlaxoSmithKline
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01086358

Purpose

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.

Condition	Intervention	Phase
Workplace Migraine Treatment	Drug: Usual prescribed triptan Drug: Treximet for migraine treatment	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label
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. Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

workplace productivity compared between migraines treated with usual triptan versus migraines treated with Treximet [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
WPAI assessment will be completed by the subjects after treatment of each of 6 workplace migraines

Secondary Outcome Measures:

comparison of patient completeness of response to migraine treatments across 6 treated workplace migraines [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
CORS 1 and CORS 2 assessments will be completed for each of 6 treated workplace migraines by each subject

Estimated Enrollment:	60
Study Start Date:	September 2009
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Drug: Usual prescribed triptan usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan
Active Comparator: 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.	Drug: Treximet for migraine treatment Treximet is the combination of sumatriptan 85 mg plus naproxen sodium 500mg

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086358

Contacts

Contact: Stewart J Tepper, MD	216/636-5549	teppers@ccf.org
Contact: Mary R Horvat, BA	216/445-1947	horvatm@ccf.org

Locations

United States, Ohio
Cleveland Clinic, 9500 Euclid Avenue, T-33	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Stewart J Tepper, MD 216-636-5549 teppers@ccf.org
Contact: Mary R Horvat, BA 216/445-1947 horvatm@ccf.org

Sponsors and Collaborators

The Cleveland Clinic

GlaxoSmithKline

More Information

Publications:

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. Epub 2009 May 27.

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.

Cleves C, Tepper SJ. Sumatriptan/naproxen sodium combination for the treatment of migraine. Expert Rev Neurother. 2008 Sep;8(9):1289-97. Review.

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.

Responsible Party:	Stewart J Tepper MD PI, Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01086358 History of Changes
Other Study ID Numbers:	09-602
Study First Received:	March 11, 2010
Last Updated:	June 21, 2011
Health Authority:	United States: Food and Drug Administration US: GlaxoSmithKline

Keywords provided by The Cleveland Clinic:

productivity
migraine
Treximet
triptan

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 24, 2012