An observational study in Migraine, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by Merck Sharp & Dohme LLC · Observational
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 216 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion criteria:
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.
Drug: Statin Therapy
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.
Drug: Statin Therapy
Investigator's choice of any statin.
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
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
Main Reason for Stopping Triptan Use
Time frame: Up to 3 months
216 of the 806 screened participants were eligible for the study and were invited to participate in the online survey.
| Milestone | Participants Enrolled in Protocol Version (V)1.1 | Participants Enrolled in Protocol V2 |
|---|---|---|
| Started | 25 | 191 |
| Completed | 25 | 99 |
| Not completed | 0 | 92 |
| Withdrew: Lack of qualifying event | 0 | 61 |
| Withdrew: Incomplete baseline data | 0 | 31 |
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 | Participants Enrolled in Protocol Version V1.1 | Participants Enrolled in Protocol V2 |
|---|---|---|
| Number of Participants Using a Triptan for Migraine Attacks | 25 | 191 |
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.
| Number of participants | Participants Enrolled in Protocol Version V1.1 | Participants Enrolled in Protocol V2 |
|---|---|---|
| Number of Participants Continuing Triptan Therapy | 25 | 174 |
| Number of partiicpants | Participants Enrolled in Protocol Version V1.1 | Participants Enrolled in Protocol V2 |
|---|---|---|
| Other medications worked better | 0 | 2 |
| Side effects of triptan | 0 | 5 |
| Insurance stopped covering cost | 0 | 2 |
| Physician or health care provider decision | 0 | 1 |
| Triptan did not work | 0 | 7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants Enrolled in Protocol Version V1.1 | — | — | — |
| Participants Enrolled in Protocol V2 | — | — | — |
All eligible particpants. 2 participants did not specify gender in the online questionnaire.
| Age, Continuous(Years) | Participants Enrolled in Protocol Version V1.1 | Participants Enrolled in Protocol V2 | Total |
|---|---|---|---|
| Mean | 41.0 ± 15.77 | 39.8 ± 13.39 | 39.9 ± 13.65 |
| Sex/Gender, Customized(Participants) | Participants Enrolled in Protocol Version V1.1 | Participants Enrolled in Protocol V2 | Total |
|---|---|---|---|
| Female | 20 | 157 | 177 |
| Male | 5 | 32 | 37 |
| Not reported | 0 | 2 | 2 |
No study locations are listed for this record.
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC