Back to resultsA Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
botulinum toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
botulinum toxin Type A
Arm Description
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Physician Global Assessment of Outcome on a 3-Point Scale
Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02147561
Brief Title
A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin Type A
Arm Type
Experimental
Arm Description
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®, onabotulinumtoxinA
Intervention Description
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Primary Outcome Measure Information:
Title
Percentage of Patients With Adverse Events
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score
Description
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
Title
Physician Global Assessment of Outcome on a 3-Point Scale
Description
Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.
Time Frame
Baseline, Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
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