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NCT02147561 Clinical Trial

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

Migraine Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02147561
Other study ID # 191622-148
Secondary ID
Status Completed
Phase Phase 4
First received May 22, 2014
Last updated April 7, 2015
Start date July 2014
Est. completion date February 2015

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

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 280
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:

- 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• botulinum toxin Type A
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.

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 Percentage of Patients with Adverse Events 28 Days No
Secondary Change from Baseline in Headache Impact Test-6 (HIT-6) Total Score Baseline, Day 28 No
Secondary Physician Global Assessment of Outcome on a 3-Point Scale Day 28 No
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