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NCT01976611 Clinical Trial

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

Headache Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01976611
Other study ID # 191622-139
Secondary ID
Status Completed
Phase N/A
First received October 30, 2013
Last updated April 7, 2015
Start date June 2012
Est. completion date February 2015

Study information
Verified date April 2015
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 402
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• botulinum toxin Type A
Botulinum toxin Type A treatment for chronic migraine as per local standard of care in clinical practice.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events and Adverse Drug Reactions 4 Years No
Primary Headache Impact Test-6 (HIT-6) Score Using a 5-Point Scale 4 Years No
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