A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
Phase 4
Completed
- Conditions
- Migraine Disorders
- Interventions
- Biological: botulinum toxin Type A
- Registration Number
- NCT02147561
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description botulinum toxin Type A botulinum toxin Type A Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.