Migraine DisordersNCT01946126
A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache
An observational study of Migraine Disorders and Headache, run by Allergan at 1 site in United States.
Trial summary
This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders, Headache
- How many people
- 459 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.
Who may be able to join
- Diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum of 15 months
- Eight (8) headache days per month for at least 1 of the preceding 15 months
Who cannot join
- Not currently diagnosed with chronic migraine, headache or migraine
- History of receiving botulinum toxin injections for the treatment of chronic migraine.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.
- Conditions
- Migraine Disorders, Headache
- Being tested
- No Intervention
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
There is no intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Migraine Diagnosis | This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. Receives: Other: No Intervention | |
| Other Headache Diagnoses | This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or Absence of Prophylactic Medication for Headache/Migraine
The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.
Measured: 15 Months
Secondary outcomes (4)
Number of Unique Prophylactic Medications for Headache/Migraine Reported
The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period.
Measured: 15 Months
Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches
The number of headache days is reported at the visit with the highest number of headaches.
Measured: 15 Months
Highest Number of Headache Days Per Month at a Qualifying Visit
The highest number of headache days per month are reported at a qualifying visit per the medical record.
Measured: 15 Months
Number of Visits for Headache Diagnosis
The number of visits for headache diagnosis is evaluated through the study period.
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2014
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.
- 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
- Retrospective
- Enrolment
- 459 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
- NCT01946126
- Sponsor's protocol ID
- GMA-BTX-CM-13-592
- Status last verified
- Feb 2016
- First submitted
- 17 Sep 2013
- Last updated
- 15 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache
- ClinicalTrials.gov ID
- NCT01946126
- Acronym / sponsor ID
- GMA-BTX-CM-13-592
- Conditions
- Migraine Disorders, Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Posted 15 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Migraine Diagnosis | – | Other: No InterventionThis is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. |
| Other Headache Diagnoses | – | Other: No InterventionThis is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.
Key inclusion criteria (2 listed)
- Diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum of 15 months
- Eight (8) headache days per month for at least 1 of the preceding 15 months
Key exclusion criteria (2 listed)
- Not currently diagnosed with chronic migraine, headache or migraine
- History of receiving botulinum toxin injections for the treatment of chronic migraine.
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 InterventionThere is no intervention in this study. | Other | Chronic Migraine Diagnosis, Other Headache Diagnoses |
Primary outcome
Presence or Absence of Prophylactic Medication for Headache/Migraine
Time frame: 15 Months
The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.
4 secondary outcomes
Number of Unique Prophylactic Medications for Headache/Migraine Reported
Time frame: 15 Months
Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches
Time frame: 15 Months
Highest Number of Headache Days Per Month at a Qualifying Visit
Time frame: 15 Months
Number of Visits for Headache Diagnosis
Time frame: 15 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Headache, run by Allergan at 1 site in United States.
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 2 inclusion and 2 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 15 Mar 2016). 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?
Presence or Absence of Prophylactic Medication for Headache/Migraine (time frame: 15 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2016.