Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2018 |
| Start Date: | September 2009 |
| End Date: | August 2016 |
A Single Center Randomized Open-Label Two Arm Crossover Study of Subject Productivity Improvement and Satisfaction With Migraine Treatment Using Treximet vs Usual Triptan
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.
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.
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.
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
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Phone: 216-444-8265
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