Migraine DisordersNCT01648530
Chronic Migraine Epidemiology and Outcomes Study
An observational study of Migraine Disorders, run by Allergan.
Trial summary
This is a population internet-based study to characterize migraine clinical course and impact on family. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- No Treatment
- How many people
- 16,789 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Nov 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with migraine
Who may be able to join
- History of migraine
- U.S. Member of Survey Panel
- Household member of study participant
- Ability to complete internet-based questionnaires
Who cannot join
- No access to internet
About this study
This is a population internet-based study to characterize migraine clinical course and impact on family.
- Conditions
- Migraine Disorders
- Being tested
- No Treatment
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No TreatmentOther
No Treatment
| Study group | Role | What they receive |
|---|---|---|
| Participants with Migraines | Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study. Receives: Other: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648530
- Sponsor's protocol ID
- GMA-BTX-12-470
- Status last verified
- Jan 2015
- First submitted
- 20 Jul 2012
- Last updated
- 29 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36701797Schwedt 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 34476122Lipton 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 31690685Buse 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 31407321Adams 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Migraine Epidemiology and Outcomes Study
- ClinicalTrials.gov ID
- NCT01648530
- Acronym / sponsor ID
- GMA-BTX-12-470
- Conditions
- Migraine Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,789 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Posted 29 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a population internet-based study to characterize migraine clinical course and impact on family.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Migraines | – | Other: No TreatmentParticipants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with migraine
Key inclusion criteria (4 listed)
- History of migraine
- U.S. Member of Survey Panel
- Household member of study participant
- Ability to complete internet-based questionnaires
Key exclusion criteria (1 listed)
- No access to internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No TreatmentNo Treatment | Other | Participants with Migraines |
Primary outcome
Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)
Time frame: Baseline
EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month.
Migraine Disability Assessment (MIDAS)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36701797Buse 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.
- Derived from this study: PubMed 34476122Schwedt 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.
- Derived from this study: PubMed 31690685Lipton 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.
- Derived from this study: PubMed 31407321Buse 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.
- Derived from this study: PubMed 25304766Adams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by Allergan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01648530, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015.