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

April 22, 2016 updated by: Allergan
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: botulinum toxin Type A
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Biological: botulinum toxin Type A
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Day 28
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.
Baseline, Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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