Migraine Disorders
Conditions
Brief summary
This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.
Interventions
BIOLOGICALbotulinum toxin Type A
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic migraine * Willing to use BOTOX® as preventative treatment for migraine
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Dysphagia | 64 weeks | Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Intractable Migraine | 64 weeks | Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away. |
Countries
Germany, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year. | 1,160 |
| Total | 1,160 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A |
|---|---|
| Age, Continuous | 46.6 Years STANDARD_DEVIATION 11.75 |
| Sex: Female, Male Female | 977 Participants |
| Sex: Female, Male Male | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 106 / 1,160 |
| serious Total, serious adverse events | 61 / 1,160 |
Outcome results
Primary
Incidence Rate of Dysphagia
Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.
Time frame: 64 weeks
Population: Treated Population: all patients who received at least 1 dose of botulinum toxin Type A
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Incidence Rate of Dysphagia | 0.4 events per 1,000 person-months |
Secondary
Incidence Rate of Intractable Migraine
Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.
Time frame: 64 weeks
Population: Treated Population: all patients who received at least 1 dose of botulinum toxin Type A
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A | Incidence Rate of Intractable Migraine | 1.6 events per 1,000 person-months |