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NCT01086358 · ClinicalTrials.gov registry record · Phase 4
Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
A Phase 4 study of Workplace Migraine Treatment, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01086358: Completed Phase 4 study of Workplace Migraine Treatment, sponsored by The Cleveland Clinic.
NCT01086358 is a Phase 4 study of Workplace Migraine Treatment that has completed, run by The Cleveland Clinic. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086358, a Phase 4 study of Workplace Migraine Treatment, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Triptan
- DRUG Treximet 85Mg-500Mg Tablet
Study Locations (1)
Ohio
- Cleveland Clinic, 9500 Euclid Avenue, C-21 - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-09 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
What the finished NCT01086358 record still lists
NCT01086358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Workplace Migraine Treatment appearing as the primary indexed condition, and to 2 interventions - of which Triptan is the first listed.
NCT01086358 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01086358 about?
NCT01086358 is a clinical study titled "Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?". 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 o...
What is the current status of trial NCT01086358?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2009-09. Estimated completion is 2016-08.
What conditions does trial NCT01086358 study?
This clinical trial studies the following conditions: Workplace Migraine Treatment.
What interventions are being tested in trial NCT01086358?
The interventions under investigation include: Triptan (DRUG), Treximet 85Mg-500Mg Tablet (DRUG).
Who is sponsoring clinical trial NCT01086358?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01086358 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01086358's enrollment target sits among peer trials
60 1125th of 2000 higher than 800 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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