Trial Outcomes & Findings for Chronic Migraine Epidemiology and Outcomes Study (NCT NCT01648530)

Results Overview

EM is defined as \<15 headache days/month and CM is defined as ≥15 headache days/month.

Recruitment status

COMPLETED

Target enrollment

16789 participants

Primary outcome timeframe

Baseline

Results posted on

2015-01-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Participants With Migraines Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
Overall Study STARTED	16789
Overall Study COMPLETED	5915
Overall Study NOT COMPLETED	10874

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chronic Migraine Epidemiology and Outcomes Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Migraines n=16789 Participants Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
Age, Continuous	40.7 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	12495 Participants n=5 Participants
Sex: Female, Male Male	4294 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All qualified participants at Baseline who returned completed survey with positive screening for migraines.

EM is defined as \<15 headache days/month and CM is defined as ≥15 headache days/month.

Outcome measures

Outcome measures
Measure	Participants With Migraines n=16789 Participants Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.	Participants With Chronic Migraine Participants who returned completed internet survey with Chronic Migraine defined as ≥15 headache days/month. No intervention was administered in this study.
Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) Episodic Migraine	91.2 percentage of participants	—
Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) Chronic Migraine	8.8 percentage of participants	—

PRIMARY outcome

Timeframe: 12 Months

Population: All qualified participants at Baseline who returned completed survey with positive screening for migraines.

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.

Outcome measures

Outcome measures
Measure	Participants With Migraines n=15313 Participants Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.	Participants With Chronic Migraine n=1476 Participants Participants who returned completed internet survey with Chronic Migraine defined as ≥15 headache days/month. No intervention was administered in this study.
Migraine Disability Assessment (MIDAS)	13.1 days Standard Deviation 22.2	60.5 days Standard Deviation 70.4

Adverse Events

Participants With Migraines

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

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place