CClinicalTrials.gg
CompletedNCT01648530Updated Jan 29, 2015Results posted

Chronic Migraine Epidemiology and Outcomes Study

An observational study in Migraine Disorders, sponsored by Allergan. Completed. Per ClinicalTrials.gov, last updated 2015-01-29.

Sponsored by Allergan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16,789
Sex
All
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Study summary

This is a population internet-based study to characterize migraine clinical course and impact on family.

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Conditions studied

  • Migraine Disorders

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03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 16,789 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with migraine

Inclusion criteria

  • History of migraine
  • U.S. Member of Survey Panel
  • Household member of study participant
  • Ability to complete internet-based questionnaires

Exclusion criteria

Exclusion Criteria:

  • No access to internet
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16,789 participants (actual)

Groups and cohorts

  • Participants with Migraines

    Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.

    Other: No Treatment

Interventions

  • OtherNo Treatment

    No Treatment

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What researchers measure

Primary outcomes

  1. 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

  2. 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

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Results

Posted Jan 29, 2015

Participant flow

Participant flow — Overall Study
MilestoneParticipants With Migraines
Started16789
Completed5915
Not completed10874

Outcome measures

PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)
percentage of participantsParticipants With Migraines
Episodic Migraine91.2
Chronic Migraine8.8
PrimaryMigraine 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
Reported as:
Mean · days
Migraine Disability Assessment (MIDAS)
daysParticipants With Episodic MigraineParticipants With Chronic Migraine
Migraine Disability Assessment (MIDAS)13.1 ± 22.260.5 ± 70.4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Participants With Migraines———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Participants With Migraines
Mean40.7 ± 14.4
Sex: Female, Male
Sex: Female, Male(Participants)Participants With Migraines
Female12495
Male4294
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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Schwedt TJ, Buse DC, Argoff CE, Reed ML, Fanning KM, Hussar CR, Adams AM, Lipton RB. Medication Overuse and Headache Burden: Results From the CaMEO Study. Neurol Clin Pract. 2021 Jun;11(3):216-226. doi: 10.1212/CPJ.0000000000001037. PubMed 34476122 ↗
  • Lipton RB, Fanning KM, Buse DC, Martin VT, Hohaia LB, Adams AM, Reed ML, Goadsby PJ. Migraine progression in subgroups of migraine based on comorbidities: Results of the CaMEO Study. Neurology. 2019 Dec 10;93(24):e2224-e2236. doi: 10.1212/WNL.0000000000008589. Epub 2019 Nov 5. PubMed 31690685 ↗
  • Buse DC, Fanning KM, Reed ML, Murray S, Dumas PK, Adams AM, Lipton RB. Life With Migraine: Effects on Relationships, Career, and Finances From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. 2019 Sep;59(8):1286-1299. doi: 10.1111/head.13613. Epub 2019 Aug 12. PubMed 31407321 ↗
  • Adams AM, Serrano D, Buse DC, Reed ML, Marske V, Fanning KM, Lipton RB. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015 Jun;35(7):563-78. doi: 10.1177/0333102414552532. Epub 2014 Oct 10. PubMed 25304766 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01648530
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Jul 24, 2012
Start date
Jul 2012
Primary completion
Nov 2013
Completion
Nov 2013
Results posted
Jan 29, 2015
Last update
Jan 29, 2015

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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