A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine

This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.

Completed

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

Botulinum toxin Type A injected across specific head and neck muscles on Day 0.

Other names: BOTOX®, onabotulinumtoxinA

Primary outcomes

Percentage of Patients With Adverse Events

Time frame: 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 outcomes

Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score

Time frame: 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

Time frame: Baseline, Day 28

Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: May 26, 2014
Registry last updated: May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed