Migraine Disorders
Conditions
Brief summary
This is a population internet-based study to characterize migraine clinical course and impact on family.
Interventions
OTHERNo Treatment
No Treatment
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* History of migraine * U.S. Member of Survey Panel * Household member of study participant * Ability to complete internet-based questionnaires
Exclusion criteria
* No access to internet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) | Baseline | EM is defined as \<15 headache days/month and CM is defined as ≥15 headache days/month. |
| Migraine Disability Assessment (MIDAS) | 12 Months | The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged. |
Participant flow
Pre-assignment details
This study was an internet survey to identify participants with Episodic Migraine (EM) and Chronic Migraine (CM). The participants were followed for up to 1 year by assessments every 3 months.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Migraines Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study. | 16,789 |
| Total | 16,789 |
Baseline characteristics
| Characteristic | Participants With Migraines |
|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 14.4 |
| Sex: Female, Male Female | 12495 Participants |
| Sex: Female, Male Male | 4294 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Migraine Disability Assessment (MIDAS)
The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged.
Time frame: 12 Months
Population: All qualified participants at Baseline who returned completed survey with positive screening for migraines.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Migraines | Migraine Disability Assessment (MIDAS) | 13.1 days | Standard Deviation 22.2 |
| Participants With Chronic Migraine | Migraine Disability Assessment (MIDAS) | 60.5 days | Standard Deviation 70.4 |
Primary
Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)
EM is defined as \<15 headache days/month and CM is defined as ≥15 headache days/month.
Time frame: Baseline
Population: All qualified participants at Baseline who returned completed survey with positive screening for migraines.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Migraines | Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) | Episodic Migraine | 91.2 percentage of participants |
| Participants With Migraines | Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) | Chronic Migraine | 8.8 percentage of participants |