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

NCT ID: NCT02147561

Last Updated: 2016-05-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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botulinum toxin Type A

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

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

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

Interventions

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botulinum toxin Type A

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

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® onabotulinumtoxinA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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191622-148

Identifier Type: -

Identifier Source: org_study_id

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