CClinicalTrials.gg
CompletedNCT01946126Updated Mar 15, 2016Results posted

A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache

An observational study in Migraine Disorders and Headache, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-15.

Sponsored by Allergan · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
459
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.

02

Conditions studied

  • Migraine Disorders
  • Headache
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 459 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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Not currently diagnosed with chronic migraine, headache or migraine
  • History of receiving botulinum toxin injections for the treatment of chronic migraine.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
459 participants (actual)

Groups and cohorts

  • Chronic Migraine Diagnosis

    This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.

    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.

    Other: No Intervention

Interventions

  • OtherNo Intervention

    There is no intervention in this study.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 Months

Secondary outcomes

  1. 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.

    Time frame: 15 Months

  2. 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.

    Time frame: 15 Months

  3. 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.

    Time frame: 15 Months

  4. Number of Visits for Headache Diagnosis

    The number of visits for headache diagnosis is evaluated through the study period.

    Time frame: 15 Months

07

Results

Posted Mar 15, 2016

Participant flow

Participant flow — Overall Study
MilestoneChronic Migraine DiagnosisOther Headache Diagnoses
Started184275
Completed184275
Not completed00

Outcome measures

PrimaryPresence 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.

Time frame:
15 Months
Reported as:
Number · Participants
Presence or Absence of Prophylactic Medication for Headache/Migraine
ParticipantsChronic Migraine DiagnosisOther Headache Diagnoses
Presence of Prophylactic Medication166227
Absence of Prophylactic Medication1848
SecondaryNumber 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.

Time frame:
15 Months
Reported as:
Mean · Medications
Number of Unique Prophylactic Medications for Headache/Migraine Reported
MedicationsChronic Migraine DiagnosisOther Headache Diagnoses
Number of Unique Prophylactic Medications for Headache/Migraine Reported2.7 ± 1.491.8 ± 1.27
SecondaryNumber 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.

Time frame:
15 Months
Reported as:
Mean · Headache Days
Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches
Headache DaysChronic Migraine DiagnosisOther Headache Diagnoses
Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches22.0 (20.6 to 23.4)19.2 (18.2 to 20.2)
SecondaryHighest 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.

Time frame:
15 Months
Reported as:
Mean · Days
Highest Number of Headache Days Per Month at a Qualifying Visit
DaysChronic Migraine DiagnosisOther Headache Diagnoses
Highest Number of Headache Days Per Month at a Qualifying Visit16.28 (14.4 to 18.2)14.01 (12.6 to 15.4)
SecondaryNumber of Visits for Headache Diagnosis

The number of visits for headache diagnosis is evaluated through the study period.

Time frame:
15 Months
Reported as:
Mean · Visits
Number of Visits for Headache Diagnosis
VisitsChronic Migraine DiagnosisOther Headache Diagnoses
Number of Visits for Headache Diagnosis4.7 ± 2.53.5 ± 1.63

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chronic Migraine Diagnosis———
Other Headache Diagnoses———

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Chronic Migraine DiagnosisOther Headache DiagnosesTotal
Mean45.02 ± 11.5445.44 ± 11.6245.3 ± 11.58
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Chronic Migraine DiagnosisOther Headache DiagnosesTotal
NumberNANANA
08

Study locations

1 site
  • Raleigh, North Carolina, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01946126
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Sep 19, 2013
Start date
Mar 2014
Primary completion
Apr 2014
Completion
Apr 2014
Results posted
Mar 15, 2016
Last update
Mar 15, 2016

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 Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion