MigraineMASTERNCT01421277
Study of Treatment Used for Migraine Headaches (MK-0974-076)
An observational study of Migraine, run by Merck Sharp & Dohme LLC.
Trial summary
This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Statin Therapy
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2011to 23 Mar 2012
- Phase
- Observational
- 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
Study population: Participants with physician-diagnosed migraine (with or without aura) who have had at least two, but not more than 8 moderate to severe migraines during the 30 days prior to screening. Participants must have received a triptan prescription 3 months (± 2 weeks) prior to being identified by the physician, must have been triptan-naïve prior to that initial prescription, and must have taken triptan medication at least once within 6 months prior to the date of informed consent for screening.
Who may be able to join
- At least 18 years of age in the United States at the time of consent
- Physician-diagnosed migraine with or without aura
- At least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening
- Initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription
- Used triptan medication at least once within 6 months prior to the date of informed consent for screening
- Internet access and able to complete online surveys via electronic data entry
Who cannot join
- Treated with triptans prior to this study
- In active litigation and compensation issues including disability dispute cases with a Government agency
- Participation in a clinical trial within the last 90 days
About this study
Official title: Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)
This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.
Read the detailed description
After study start, the Protocol was amended to clarifiy that the first triptan prescription must have been received by the participant within a time window of 3 months (± 2 weeks) prior to the participant being identified by the Investigator, and could be enrolled into the study within 6 months of taking the prescribed triptan medication for the first time and that use of a sample triptan would not disqualify a participant as long as the sample was of the same triptan that was eventually prescribed.
- Conditions
- Migraine
- Being tested
- Statin Therapy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin TherapyDrug
Investigator's choice of any statin.
| Study group | Role | What they receive |
|---|---|---|
| Participants Enrolled in Protocol Version (V)1.1 | Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study. Receives: Drug: Statin Therapy | |
| Participants Enrolled in Protocol V2 | Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study. Receives: Drug: Statin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Using a Triptan for Migraine Attacks
Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.
Measured: Up to 3 months
Number of Participants Continuing Triptan Therapy
Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.
Measured: Up to 3 monoths
Main Reason for Stopping Triptan Use
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study start19 May 2011
- Primary completion23 Mar 2012
- Study completion23 Mar 2012
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.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421277
- Sponsor's protocol ID
- 0974-076
- Acronym
- MASTER
- Status last verified
- May 2017
- First submitted
- 28 Jul 2011
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)
- ClinicalTrials.gov ID
- NCT01421277
- Acronym / sponsor ID
- MASTER / 0974-076
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 19 May 2011 (actual)
- Primary completion
- 23 Mar 2012 (actual)
- Study completion
- 23 Mar 2012 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.
Detailed description
After study start, the Protocol was amended to clarifiy that the first triptan prescription must have been received by the participant within a time window of 3 months (± 2 weeks) prior to the participant being identified by the Investigator, and could be enrolled into the study within 6 months of taking the prescribed triptan medication for the first time and that use of a sample triptan would not disqualify a participant as long as the sample was of the same triptan that was eventually prescribed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants Enrolled in Protocol Version (V)1.1 | – | Drug: Statin TherapyParticipants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study. |
| Participants Enrolled in Protocol V2 | – | Drug: Statin TherapyParticipants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with physician-diagnosed migraine (with or without aura) who have had at least two, but not more than 8 moderate to severe migraines during the 30 days prior to screening. Participants must have received a triptan prescription 3 months (± 2 weeks) prior to being identified by the physician, must have been triptan-naïve prior to that initial prescription, and must have taken triptan medication at least once within 6 months prior to the date of informed consent for screening.
Key inclusion criteria (6 listed)
- At least 18 years of age in the United States at the time of consent
- Physician-diagnosed migraine with or without aura
- At least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening
- Initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription
- Used triptan medication at least once within 6 months prior to the date of informed consent for screening
Key exclusion criteria (3 listed)
- Treated with triptans prior to this study
- In active litigation and compensation issues including disability dispute cases with a Government agency
- Participation in a clinical trial within the last 90 days
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 |
|---|---|---|
| Statin TherapyInvestigator's choice of any statin. | Drug | Participants Enrolled in Protocol V2, Participants Enrolled in Protocol Version (V)1.1 |
Primary outcome
Number of Participants Using a Triptan for Migraine Attacks
Time frame: Up to 3 months
Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.
Number of Participants Continuing Triptan Therapy
Time frame: Up to 3 monoths
Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.
Main Reason for Stopping Triptan Use
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Merck Sharp & Dohme LLC.
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 3 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: stopped early, as of the sponsor's last update on 20 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2014). 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?
Number of Participants Using a Triptan for Migraine Attacks (time frame: Up to 3 months). The study lists 3 primary outcomes in all. 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 20 Jun 2017.