Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? (TRXvUsualTrptn)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The Cleveland Clinic
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01086358
First received: March 11, 2010
Last updated: June 23, 2014
Last verified: June 2014
  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:


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: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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