BOTOX® Prophylaxis in Patients With Chronic Migraine
Completed
- Conditions
- Migraine Disorders
- Interventions
- Biological: botulinum toxin Type A
- Registration Number
- NCT01432379
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1168
Inclusion Criteria
- Diagnosis of chronic migraine
- Willing to use BOTOX® as preventative treatment for migraine
Exclusion Criteria
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description botulinum toxin Type A 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.