Chronic Migraine, Headaches
Conditions
Brief summary
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.
Interventions
BIOLOGICALonabotulinumtoxinA
Previous treatment with onabotulinumtoxinA for Chronic Migraine.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 15 or more headache days over a 30 day period * A minimum of 7 treatment cycles with onabotulinumtoxinA
Exclusion criteria
* Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Number of Headache Days | Treatment Cycle 7 (approximately 1.5 years) | The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 43.97 Years STANDARD_DEVIATION 11.07 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Change From Baseline in the Number of Headache Days
The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.
Time frame: Treatment Cycle 7 (approximately 1.5 years)
Population: All subjects who satisfied the inclusion and exclusion criteria
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in the Number of Headache Days | Baseline | 19.08 Days | Standard Deviation 5.76 |
| All Participants | Change From Baseline in the Number of Headache Days | Change from Baseline at Cycle 7 (approx 1.5 years) | 6.25 Days | Standard Deviation 6.76 |