Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Chronic Migraine in Korea

Completed

• Conditions: Migraine Disorders; Headache
• Interventions: Biological: botulinum toxin Type A

• Registration Number: NCT01976611
• Lead Sponsor: Allergan

Brief Summary

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

• Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BOTOX®	botulinum toxin Type A	Patients who receive botulinum toxin Type A (BOTOX®) treatment for chronic migraine as per local standard of care in clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events and Adverse Drug Reactions	4 Years
Headache Impact Test-6 (HIT-6) Score Using a 5-Point Scale	4 Years