NCT01648530

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,789

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 29, 2015

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

July 20, 2012

Results QC Date

January 21, 2015

Last Update Submit

January 21, 2015

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline

  • 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.

    12 Months

Study Arms (1)

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

No TreatmentOTHER

No Treatment

Participants with Migraines

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with migraine

You may qualify if:

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

You may not qualify if:

  • No access to internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Buse DC, Nahas SJ, Stewart WBF, Armand CE, Reed ML, Fanning KM, Manack Adams A, Lipton RB. Optimized Acute Treatment of Migraine Is Associated With Greater Productivity in People With Migraine: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. J Occup Environ Med. 2023 Apr 1;65(4):e261-e268. doi: 10.1097/JOM.0000000000002801. Epub 2023 Jan 25.

    PMID: 36701797DERIVED

  • 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.

    PMID: 34476122DERIVED

  • 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.

    PMID: 31690685DERIVED

  • 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.

    PMID: 31407321DERIVED

  • 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.

    PMID: 25304766DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 24, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 29, 2015

Results First Posted

January 29, 2015

Record last verified: 2015-01