Migraine DisordersNCT01381497
Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy
An observational study of Migraine Disorders, run by GlaxoSmithKline.
Trial summary
Migraine headaches lead to absenteeism and can restrict on-the-job productivity (presenteeism) for employed migraine sufferers. Effective migraine treatments should reduce migraine-associated productivity losses and return migraineurs to normal functioning within a few hours of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap) and Triptan monotherapy
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult males and females aged 18 to 65 with a diagnosis of migraine disorder who are employed and scheduled to work at least 30 hours per week during a day time shift. Patients must be treating migraines with either a combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap) or oral triptan monotherapy as prescribed prior to study start. Patients will be recruited from up to 30 investigative sites.
Who may be able to join
- Age 18 to 65
- Currently treating migraine attacks with SumaRT/Nap or oral triptan monotherapy
- Have a diagnosis of migraine with or without aura (2004 International Classification of Headache Disorders (ICHD)-II criteria)
- Have had at least 2 but not more than 8 migraine attacks per month in the previous 2 months
- Score 56 or higher on the Headache Impact Test 6 (HIT-6)
- Be actively employeed for at least 30 hours per week and working a day time shift (beginning between 6 and 11 AM)
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- Have experienced and treated a disabling migraine in the work place during the month prior to screening
- Be willing to treat a mild, moderate, or severe migraine in the work place with usual medication (SumaRT/Nap or oral triptan alone)
- Be willing to adhere to protocol requirements including, but not limited to, hourly phone calls from the Interactive Voice-Activated Recording System (IVRS) and clinic visits
- Have an active cell phone with a plan that has sufficient monthly minutes during the study period to collect data via IVRS and be willing to provide their cell phone number to the study team
- Consent to phone the IVRS at the onset of a migraine attack during or prior to the workday and receive up to 8 phone calls (1 to 2 minutes each) during the workday.
- Be able to distinguish migraine attacks from other headache types
- Be able to hear, understand, and verbally answer questions from the IVRS in English
- Be willing and able to give written informed consent to participate in the study
- Female subjects of childbearing potential must use a reliable method of birth control as agreed upon by their investigator or male partner who is physiologically or surgically sterile. Any subject taking oral contraceptives must be on a stable regimen for at least two months prior to screening.
Who cannot join
- Subject often treats migraine attacks with a combination of a single entity triptan and any other medication
- Has 15 or more headache days per month in total, retinal (ICH-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches
- Has a HIT-6 score below 56 at screening
- Works an evening or night shift or works from home
- Has hypersensitivity, allergy, intolerance, or contraindication to any triptan or non-steriodal anti-inflammatory (NSAID) drug including aspirin and all sumatriptan and naproxen preparations.
- Has nasal polyps or asthma
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- Is currently taking, or has taken in the 2 weeks prior to screening, a migraine prophylactic medication containing methylsergide or dihydroergotamine; or is takign a medication that is not stablized (i.e. change of dose within the previous two months) for intermittant migraine prophylaxis or for a co-morbid condition that is not stablized
- Has a recent history of regular use of opioids or barbituates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month during any month over the last 3 months
- Has taken or plans to take a monoamine oxidase (MAOI) inhibitor including herbal preparations containing St. John's Wort (Hypericum perforatum) anytime within the 2 weeks prior to screening through 2 weeks post final study treatment
- Is pregnant, actively trying to become pregnant, or breast feeding
- Has evidence of alcohol or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgement, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial
- Has participated in an investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study
About this study
Migraine headaches lead to absenteeism and can restrict on-the-job productivity (presenteeism) for employed migraine sufferers. Effective migraine treatments should reduce migraine-associated productivity losses and return migraineurs to normal functioning within a few hours of treatment.
This study is an observational, multicenter, parallel-group study of employed patients who have been prescribed either a combination product containing sumatriptan and naproxen sodium (SumaRT/Nap) or oral triptan monotherapy to treat acute migraine attacks. The study will report results from 4 migraine attacks per patient. Eligible migraine attacks will be defined as those preceded by a 24-hour, headache-free period with onset between 2 hours prior to the start of and 4 hours before the end of a scheduled work shift. Data will be collected at time of treatment and hourly until the end of the attack or the end of the workday. To estimate baseline productivity, data will be collected from 50 randomly selected subjects during a migraine-free workday.
Read more
The primary objective of this study is to compare migraine-related, work productivity losses (absenteeism and presenteeism) reported by patients treated with SumaRT/Nap to losses reported by patients treated with triptan monotherapy. The null hypothesis is that no difference will be observed between the number of hours of productivity lost for patients who treat workday migraine attacks with SumaRT/Nap and patients who treat migraine attacks with an oral triptan alone. The alternative hypotheses are that patients in either treatment group experience significantly fewer hours of lost productivity associated with migraine compared to patients in the other treatment group.
The secondary objectives of this study are to measure the time between treatment and return to patient-reported, normal functioning; to evaluate rescue medication use after initial treatment; to measure total productivity loss following treatment at hourly time points; and to estimate the probability of absenteeism when a migraine begins before or during the workday. The null hypotheses for the secondary endpoints are that no differences will be observed between the results reported by patients treating with SumaRT/Nap and patients treating with triptan monotherapy. The alternative hypotheses are that either treatment is superior to the other for each endpoint.
- Conditions
- Migraine Disorders
- Being tested
- Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap), Triptan monotherapy
- Keywords
- presenteeism, migraine disorders, work productivity, triptan, sumatriptan and naproxen sodium, absenteeism
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap)Drug
Also called Treximet®
This is an observational study and patients were prescribed this medication before study start
Triptan monotherapyDrug
Also called Zomig® is a registered trademark of AstraZeneca, Amerge® is a registered trademark of GlaxoSmithKline, Axert® is a registered trademark of Pharmacia, Frova® is a registered trademark of Elan Pharmaceuticals/UCB Pharma
This is an observational study and patients reported a previous triptan monotherapy prescription. Drugs of interested included naratriptan, sumatriptan, rizatriptan, frovatriptan, almotriptan, eletriptan, zolmitriptan
| Study group | Role | What they receive |
|---|---|---|
| Employed migraine sufferers | Diagnosed adult migraine sufferers who are employed at least 30 hours per week during a daytime shift Receives: Drug: Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap); Drug: Triptan monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Lost Productivity (absenteeism and presenteeism) measured by Lost Time Equivalents
Lost Time Equivalents = hours missed from work + [(100% - % effectiveness while working with symptoms)/100 x hours working with symptoms].
Measured: Four qualifying migraine attacks must occur within 16 weeks of enrollment. Data collection begins at time of treatment and continues in hourly intervals until the end of the migraine attack or the end of the workday.
Secondary outcomes (4)
Percentage of patients returning to normal functioning as measured by the Clinical Disability Questionnaire (CDQ)
The CDQ uses one question to assess ability to perform normal or usual activities. Responses are recorded on a 5-point scale, where 1 is "normal/not impaired", 2 is "mildly impaired", 3 is "moderately impaired", 4 is "severely impaired", and 5 is '"required bedrest". Normal functioning is considered a score of "1"
Measured: At time of treatment for a qualifying attack and at hourly intervals post treatment until end of migraine attack or end of workday
Rescue medication
For patients who need pain relief in addition to the study treatment, rescue medication is allowed and measured. Type of rescue medication will be allowed at the discretion of the investigator and within the guidelines of the package insert for the study medication
Measured: Rescue medication is prohibited within 2 hours of study treatment administration. Rescue medication use is measured between 2 and 4 hours post treatment
Number of missed work hours and presenteeism hours lost following treatment measured in hours
Measured as per the primary endpoint and reported hourly
Measured: At time of treatment for a qualifying attack and hourly intervals post treatment until end of migraine attack or end of workday
Probability of absenteeism during a morning migraine attack
A subgroup analysis will be conducted to provide information about the probability that patients will be absent if the migraine onset occurs in the morning
Measured: At time of treatment for a qualifying attack and hourly intervals post treatment until end of migraine attack or end of workday
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381497
- Sponsor's protocol ID
- 112617
- Status last verified
- Aug 2012
- First submitted
- 23 Jun 2011
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy
- ClinicalTrials.gov ID
- NCT01381497
- Acronym / sponsor ID
- 112617
- Conditions
- Migraine Disorders
- Keywords
- presenteeism, migraine disorders, work productivity, triptan, sumatriptan and naproxen sodium, absenteeism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Migraine headaches lead to absenteeism and can restrict on-the-job productivity (presenteeism) for employed migraine sufferers. Effective migraine treatments should reduce migraine-associated productivity losses and return migraineurs to normal functioning within a few hours of treatment.
This study is an observational, multicenter, parallel-group study of employed patients who have been prescribed either a combination product containing sumatriptan and naproxen sodium (SumaRT/Nap) or oral triptan monotherapy to treat acute migraine attacks. The study will report results from 4 migraine attacks per patient. Eligible migraine attacks will be defined as those preceded by a 24-hour, headache-free period with onset between 2 hours prior to the start of and 4 hours before the end of a scheduled work shift. Data will be collected at time of treatment and hourly until the end of the attack or the end of the workday. To estimate baseline productivity, data will be collected from 50 randomly selected subjects during a migraine-free workday.
The primary objective of this study is to compare migraine-related, work productivity losses (absenteeism and presenteeism) reported by patients treated with SumaRT/Nap to losses reported by patients treated with triptan monotherapy. The null hypothesis is that no difference will be observed between the number of hours of productivity lost for patients who treat workday migraine attacks with SumaRT/Nap and patients who treat migraine attacks with an oral triptan alone. The alternative hypotheses are that patients in either treatment group experience significantly fewer hours of lost productivity associated with migraine compared to patients in the other treatment group.
The secondary objectives of this study are to measure the time between treatment and return to patient-reported, normal functioning; to evaluate rescue medication use after initial treatment; to measure total productivity loss following treatment at hourly time points; and to estimate the probability of absenteeism when a migraine begins before or during the workday. The null hypotheses for the secondary endpoints are that no differences will be observed between the results reported by patients treating with SumaRT/Nap and patients treating with triptan monotherapy. The alternative hypotheses are that either treatment is superior to the other for each endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Employed migraine sufferers | – | Drug: Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap), Drug: Triptan monotherapyDiagnosed adult migraine sufferers who are employed at least 30 hours per week during a daytime shift |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males and females aged 18 to 65 with a diagnosis of migraine disorder who are employed and scheduled to work at least 30 hours per week during a day time shift. Patients must be treating migraines with either a combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap) or oral triptan monotherapy as prescribed prior to study start. Patients will be recruited from up to 30 investigative sites.
Key inclusion criteria (15 listed)
- Age 18 to 65
- Currently treating migraine attacks with SumaRT/Nap or oral triptan monotherapy
- Have a diagnosis of migraine with or without aura (2004 International Classification of Headache Disorders (ICHD)-II criteria)
- Have had at least 2 but not more than 8 migraine attacks per month in the previous 2 months
- Score 56 or higher on the Headache Impact Test 6 (HIT-6)
Key exclusion criteria (12 listed)
- Subject often treats migraine attacks with a combination of a single entity triptan and any other medication
- Has 15 or more headache days per month in total, retinal (ICH-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches
- Has a HIT-6 score below 56 at screening
- Works an evening or night shift or works from home
- Has hypersensitivity, allergy, intolerance, or contraindication to any triptan or non-steriodal anti-inflammatory (NSAID) drug including aspirin and all sumatriptan and naproxen preparations.
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 |
|---|---|---|
| Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap)Also: Treximet®This is an observational study and patients were prescribed this medication before study start | Drug | Employed migraine sufferers |
| Triptan monotherapyAlso: Zomig® is a registered trademark of AstraZeneca, Amerge® is a registered trademark of GlaxoSmithKline, Axert® is a registered trademark of Pharmacia, Frova® is a registered trademark of Elan Pharmaceuticals/UCB PharmaThis is an observational study and patients reported a previous triptan monotherapy prescription. Drugs of interested included naratriptan, sumatriptan, rizatriptan, frovatriptan, almotriptan, eletriptan, zolmitriptan | Drug | Employed migraine sufferers |
Primary outcome
Total Lost Productivity (absenteeism and presenteeism) measured by Lost Time Equivalents
Time frame: Four qualifying migraine attacks must occur within 16 weeks of enrollment. Data collection begins at time of treatment and continues in hourly intervals until the end of the migraine attack or the end of the workday.
Lost Time Equivalents = hours missed from work + [(100% - % effectiveness while working with symptoms)/100 x hours working with symptoms].
4 secondary outcomes
Percentage of patients returning to normal functioning as measured by the Clinical Disability Questionnaire (CDQ)
Time frame: At time of treatment for a qualifying attack and at hourly intervals post treatment until end of migraine attack or end of workday
Rescue medication
Time frame: Rescue medication is prohibited within 2 hours of study treatment administration. Rescue medication use is measured between 2 and 4 hours post treatment
Number of missed work hours and presenteeism hours lost following treatment measured in hours
Time frame: At time of treatment for a qualifying attack and hourly intervals post treatment until end of migraine attack or end of workday
Probability of absenteeism during a morning migraine attack
Time frame: At time of treatment for a qualifying attack and hourly intervals post treatment until end of migraine attack or end of workday
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by GlaxoSmithKline.
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 15 inclusion and 12 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 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Lost Productivity (absenteeism and presenteeism) measured by Lost Time Equivalents (time frame: Four qualifying migraine attacks must occur within 16 weeks of enrollment. Data collection begins at time of treatment and continues in hourly intervals until the end of the migraine attack or the end of the workday.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2012.