Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 216
- Primary Endpoint
- Number of Participants Using a Triptan for Migraine Attacks
Study Overview
Brief 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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Statin Therapy (Drug)
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.
Intervention: Statin Therapy (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported