Headache, Migraine Disorders
Conditions
Brief summary
This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.
Interventions
OTHERNo Intervention
There is no intervention in this study.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
* Not currently diagnosed with chronic migraine, headache or migraine * History of receiving botulinum toxin injections for the treatment of chronic migraine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence or Absence of Prophylactic Medication for Headache/Migraine | 15 Months | The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Unique Prophylactic Medications for Headache/Migraine Reported | 15 Months | The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period. |
| Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches | 15 Months | The number of headache days is reported at the visit with the highest number of headaches. |
| Highest Number of Headache Days Per Month at a Qualifying Visit | 15 Months | The highest number of headache days per month are reported at a qualifying visit per the medical record. |
| Number of Visits for Headache Diagnosis | 15 Months | The number of visits for headache diagnosis is evaluated through the study period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Migraine Diagnosis This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study. | 184 |
| 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. | 275 |
| Total | 459 |
Baseline characteristics
| Characteristic | Chronic Migraine Diagnosis | Other Headache Diagnoses | Total |
|---|---|---|---|
| Age, Continuous | 45.02 Years STANDARD_DEVIATION 11.54 | 45.44 Years STANDARD_DEVIATION 11.62 | 45.3 Years STANDARD_DEVIATION 11.58 |
| Sex/Gender, Customized | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: All enrolled subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Migraine Diagnosis | Presence or Absence of Prophylactic Medication for Headache/Migraine | Presence of Prophylactic Medication | 166 Participants |
| Chronic Migraine Diagnosis | Presence or Absence of Prophylactic Medication for Headache/Migraine | Absence of Prophylactic Medication | 18 Participants |
| Other Headache Diagnoses | Presence or Absence of Prophylactic Medication for Headache/Migraine | Presence of Prophylactic Medication | 227 Participants |
| Other Headache Diagnoses | Presence or Absence of Prophylactic Medication for Headache/Migraine | Absence of Prophylactic Medication | 48 Participants |
Secondary
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
Population: All enrolled subjects with data for this outcome measure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Chronic Migraine Diagnosis | Highest Number of Headache Days Per Month at a Qualifying Visit | 16.28 Days |
| Other Headache Diagnoses | Highest Number of Headache Days Per Month at a Qualifying Visit | 14.01 Days |
Secondary
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
Population: All enrolled subjects
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Chronic Migraine Diagnosis | Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches | 22.0 Headache Days |
| Other Headache Diagnoses | Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches | 19.2 Headache Days |
Secondary
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
Population: All enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic Migraine Diagnosis | Number of Unique Prophylactic Medications for Headache/Migraine Reported | 2.7 Medications | Standard Deviation 1.49 |
| Other Headache Diagnoses | Number of Unique Prophylactic Medications for Headache/Migraine Reported | 1.8 Medications | Standard Deviation 1.27 |
Secondary
Number of Visits for Headache Diagnosis
The number of visits for headache diagnosis is evaluated through the study period.
Time frame: 15 Months
Population: All enrolled subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic Migraine Diagnosis | Number of Visits for Headache Diagnosis | 4.7 Visits | Standard Deviation 2.5 |
| Other Headache Diagnoses | Number of Visits for Headache Diagnosis | 3.5 Visits | Standard Deviation 1.63 |