Workplace Migraine TreatmentPhase 4NCT01086358
Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
A Phase 4 study testing Triptan and Treximet 85Mg-500Mg Tablet in people with Workplace Migraine Treatment, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Workplace Migraine Treatment
- What is being tested?
- Triptan and Treximet 85Mg-500Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, 9500 Euclid Avenue, C-21
Cleveland, Ohio, 44195
About this study
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
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.
Read the 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.
- Conditions
- Workplace Migraine Treatment
- Being tested
- Triptan, Treximet 85Mg-500Mg Tablet
- Keywords
- Productivity, Migraine, Treximet, Triptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriptanDrug
Also called Sumatriptan,rizatriptan,naratriptan,almotriptan,eletriptan,zolmitriptan
Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan
Treximet 85Mg-500Mg TabletDrug
Also called Sumatriptan 85 mg plus naproxen sodium 500 mg
Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium
| Study group | Role | What they receive |
|---|---|---|
| Triptan | Active comparator | Arm 1 subjects began with their prescribed triptan Receives: Drug: Triptan |
| Treximet 85Mg-500Mg Tablet | Active comparator | Arm 2 subjects began with Treximet (sumatriptan 85 mg/naproxen sodium 500 mg) Receives: Drug: Treximet 85Mg-500Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Workplace Productivity and Activity Impairment Scale (WPAI).
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 all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
Measured: 6 months
Secondary outcomes (3)
Lost Workplace Productivity
This outcome measure was lost workplace productivity 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 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 all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
Measured: 6 months
Lost Activity Time
This outcome measure was lost 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 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 all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
Measured: 6 Months
Favorable Response on Migraine-ACT
The Migraine-ACT is a 4-item scale with yes/no responses. A score of 3 or more is considered favorable. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The Migraine-ACT is reported as a binary measure (3 or more positive responses). The outcome presented included the percentage with a score of 3 or more, and the Odds ratio comparing the two treatments.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Workplace Migraine TreatmentStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Currax Pharmaceuticals
- Responsible party
- Principal investigator, Jennifer Kriegler, MD, The Cleveland Clinic
- Investigators
- Jennifer S Kriegler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086358
- Sponsor's protocol ID
- 09-602
- Status last verified
- Mar 2018
- First submitted
- 11 Mar 2010
- Last updated
- 1 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
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. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.
PubMed 19486178Dowson 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.
PubMed 15265257Cleves 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.
PubMed 18759540Brandes 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.
PubMed 17405970
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01086358
- Acronym / sponsor ID
- 09-602
- Conditions
- Workplace Migraine Treatment
- Keywords
- Productivity, Migraine, Treximet, Triptan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Currax Pharmaceuticals
- Study start
- Sep 2009 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Mar 2010 (estimated)
- Results
- Posted 1 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Triptan | Active comparator | Drug: TriptanArm 1 subjects began with their prescribed triptan |
| Treximet 85Mg-500Mg Tablet | Active comparator | Drug: Treximet 85Mg-500Mg TabletArm 2 subjects began with Treximet (sumatriptan 85 mg/naproxen sodium 500 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriptanAlso: Sumatriptan,rizatriptan,naratriptan,almotriptan,eletriptan,zolmitriptanUsual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan | Drug | Triptan |
| Treximet 85Mg-500Mg TabletAlso: Sumatriptan 85 mg plus naproxen sodium 500 mgTreximet is 85 mg sumatriptan plus 500 mg naproxen sodium | Drug | Treximet 85Mg-500Mg Tablet |
Primary outcome
Workplace Productivity and Activity Impairment Scale (WPAI).
Time frame: 6 months
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 all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
3 secondary outcomes
Lost Workplace Productivity
Time frame: 6 months
Lost Activity Time
Time frame: 6 Months
Favorable Response on Migraine-ACT
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19486178Mathew 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.
- Background: PubMed 15265257Dowson 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.
- Background: PubMed 18759540Cleves 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.
- Background: PubMed 17405970Brandes 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer S Kriegler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triptan and Treximet 85Mg-500Mg Tablet in people with Workplace Migraine Treatment, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Workplace Productivity and Activity Impairment Scale (WPAI). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01086358, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.