A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
1 other identifier
interventional
280
1 country
1
Brief Summary
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
May 27, 2016
CompletedMay 27, 2016
April 1, 2016
7 months
May 22, 2014
March 9, 2016
April 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
28 Days
Secondary Outcomes (2)
Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score
Baseline, Day 28
Physician Global Assessment of Outcome on a 3-Point Scale
Baseline, Day 28
Study Arms (1)
botulinum toxin Type A
EXPERIMENTALBotulinum toxin Type A injected across specific head and neck muscles on Day 0.
Interventions
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Eligibility Criteria
You may qualify if:
- Ethnically Korean with a diagnosis of chronic migraine
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2014
First Posted
May 26, 2014
Study Start
July 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
May 27, 2016
Results First Posted
May 27, 2016
Record last verified: 2016-04