Trial Outcomes & Findings for Study of Treatment Used for Migraine Headaches (MK-0974-076) (NCT NCT01421277)
NCT ID: NCT01421277
Last Updated: 2017-06-20
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
216 participants
Primary outcome timeframe
Up to 3 months
Results posted on
2017-06-20
Participant Flow
216 of the 806 screened participants were eligible for the study and were invited to participate in the online survey.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
191
|
|
Overall Study
COMPLETED
|
25
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
92
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lack of qualifying event
|
0
|
61
|
|
Overall Study
Incomplete baseline data
|
0
|
31
|
Baseline Characteristics
Study of Treatment Used for Migraine Headaches (MK-0974-076)
Baseline characteristics by cohort
| Measure |
Participants Enrolled in Protocol Version V1.1
n=25 Participants
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.
|
Participants Enrolled in Protocol V2
n=191 Participants
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.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.0 Years
STANDARD_DEVIATION 15.77 • n=5 Participants
|
39.8 Years
STANDARD_DEVIATION 13.39 • n=7 Participants
|
39.9 Years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
20 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
5 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Not reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: All screened participants who were fully eligible for the study.
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.
Outcome measures
| Measure |
Participants Enrolled in Protocol V2
n=191 Participants
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.
|
Participants Enrolled in Protocol Version V1.1
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants Using a Triptan for Migraine Attacks
|
191 Number of participants
|
25 Number of participants
|
PRIMARY outcome
Timeframe: Up to 3 monothsPopulation: All screened participants who were fully eligible for the study.
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.
Outcome measures
| Measure |
Participants Enrolled in Protocol V2
n=191 Participants
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.
|
Participants Enrolled in Protocol Version V1.1
n=25 Participants
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.
|
|---|---|---|
|
Number of Participants Continuing Triptan Therapy
|
174 Number of participants
|
25 Number of participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: All screened participants who were fully eligible for the study.
Outcome measures
| Measure |
Participants Enrolled in Protocol V2
n=191 Participants
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.
|
Participants Enrolled in Protocol Version V1.1
n=25 Participants
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.
|
|---|---|---|
|
Main Reason for Stopping Triptan Use
Other medications worked better
|
2 Number of partiicpants
|
0 Number of partiicpants
|
|
Main Reason for Stopping Triptan Use
Side effects of triptan
|
5 Number of partiicpants
|
0 Number of partiicpants
|
|
Main Reason for Stopping Triptan Use
Insurance stopped covering cost
|
2 Number of partiicpants
|
0 Number of partiicpants
|
|
Main Reason for Stopping Triptan Use
Physician or health care provider decision
|
1 Number of partiicpants
|
0 Number of partiicpants
|
|
Main Reason for Stopping Triptan Use
Triptan did not work
|
7 Number of partiicpants
|
0 Number of partiicpants
|
Adverse Events
Participants Enrolled in Protocol Version V1.1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Enrolled in Protocol V2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER