Migraine
Conditions
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.
Interventions
DRUGStatin Therapy
Investigator's choice of any statin.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Using a Triptan for Migraine Attacks | 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 | 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 | Up to 3 months | — |
Participant flow
Recruitment details
216 of the 806 screened participants were eligible for the study and were invited to participate in the online survey.
Participants by arm
| Arm | Count |
|---|---|
| Participants Enrolled in Protocol Version V1.1 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. | 25 |
| 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. | 191 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete baseline data | 0 | 31 |
| Overall Study | Lack of qualifying event | 0 | 61 |
Baseline characteristics
| Characteristic | Participants Enrolled in Protocol Version V1.1 | Participants Enrolled in Protocol V2 | Total |
|---|---|---|---|
| Age, Continuous | 41.0 Years STANDARD_DEVIATION 15.77 | 39.8 Years STANDARD_DEVIATION 13.39 | 39.9 Years STANDARD_DEVIATION 13.65 |
| Sex/Gender, Customized Female | 20 Participants | 157 Participants | 177 Participants |
| Sex/Gender, Customized Male | 5 Participants | 32 Participants | 37 Participants |
| Sex/Gender, Customized Not reported | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Main Reason for Stopping Triptan Use
Time frame: Up to 3 months
Population: All screened participants who were fully eligible for the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Enrolled in Protocol Version V1.1 | Main Reason for Stopping Triptan Use | Insurance stopped covering cost | 0 Number of partiicpants |
| Participants Enrolled in Protocol Version V1.1 | Main Reason for Stopping Triptan Use | Physician or health care provider decision | 0 Number of partiicpants |
| Participants Enrolled in Protocol Version V1.1 | Main Reason for Stopping Triptan Use | Other medications worked better | 0 Number of partiicpants |
| Participants Enrolled in Protocol Version V1.1 | Main Reason for Stopping Triptan Use | Side effects of triptan | 0 Number of partiicpants |
| Participants Enrolled in Protocol Version V1.1 | Main Reason for Stopping Triptan Use | Triptan did not work | 0 Number of partiicpants |
| Participants Enrolled in Protocol V2 | Main Reason for Stopping Triptan Use | Triptan did not work | 7 Number of partiicpants |
| Participants Enrolled in Protocol V2 | Main Reason for Stopping Triptan Use | Insurance stopped covering cost | 2 Number of partiicpants |
| Participants Enrolled in Protocol V2 | Main Reason for Stopping Triptan Use | Side effects of triptan | 5 Number of partiicpants |
| Participants Enrolled in Protocol V2 | Main Reason for Stopping Triptan Use | Physician or health care provider decision | 1 Number of partiicpants |
| Participants Enrolled in Protocol V2 | Main Reason for Stopping Triptan Use | Other medications worked better | 2 Number of partiicpants |
Primary
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.
Time frame: Up to 3 monoths
Population: All screened participants who were fully eligible for the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Enrolled in Protocol Version V1.1 | Number of Participants Continuing Triptan Therapy | 25 Number of participants |
| Participants Enrolled in Protocol V2 | Number of Participants Continuing Triptan Therapy | 174 Number of participants |
Primary
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.
Time frame: Up to 3 months
Population: All screened participants who were fully eligible for the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Enrolled in Protocol Version V1.1 | Number of Participants Using a Triptan for Migraine Attacks | 25 Number of participants |
| Participants Enrolled in Protocol V2 | Number of Participants Using a Triptan for Migraine Attacks | 191 Number of participants |