Migraine Disorders
Conditions
Brief summary
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.
Interventions
BIOLOGICALbotulinum toxin Type A
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ethnically Korean with a diagnosis of chronic migraine
Exclusion criteria
* Anticipated need for botulinum toxin treatment for any reason other than chronic migraine during the study * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Adverse Events | 28 Days | An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score | Baseline, Day 28 | The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening. |
| Physician Global Assessment of Outcome on a 3-Point Scale | Baseline, Day 28 | Physicians evaluated patient migraines as improved, no change, or worse compared to baseline. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A Botulinum toxin Type A injected across specific head and neck muscles on Day 0. | 279 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Subjects who didn't receive BOTOX | 1 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A |
|---|---|
| Age, Continuous | 49.81 Years STANDARD_DEVIATION 14.56 |
| Sex: Female, Male Female | 229 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 279 |
| serious Total, serious adverse events | 4 / 279 |
Outcome results
Primary
Percentage of Patients With Adverse Events
An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Time frame: 28 Days
Population: Safety Population: patients enrolled in the study who received study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Percentage of Patients With Adverse Events | 24.37 Percentage of Patients |
Secondary
Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score
The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
Time frame: Baseline, Day 28
Population: Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A | Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score | Baseline | 67.54 Scores on a Scale | Standard Deviation 5.83 |
| Botulinum Toxin Type A | Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score | Change from Baseline at Day 28 | -7.32 Scores on a Scale | Standard Deviation 7.98 |
Secondary
Physician Global Assessment of Outcome on a 3-Point Scale
Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.
Time frame: Baseline, Day 28
Population: Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Physician Global Assessment of Outcome on a 3-Point Scale | Improved | 200 Patients |
| Botulinum Toxin Type A | Physician Global Assessment of Outcome on a 3-Point Scale | No Change | 72 Patients |
| Botulinum Toxin Type A | Physician Global Assessment of Outcome on a 3-Point Scale | Worse | 4 Patients |