A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine

November 9, 2016 updated by: Allergan
This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

716

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

  • Australia
      • Adelaide, Australia, SA 5000
        • Dr. Joseph Frasca
      • Burwood, Australia, NSW 2134
        • Dr. Con Yiannikas
      • Melbourne, Australia, VIC 3000
        • Associate Professor Richard Stark
      • Richmond, Australia, VIC 3051
        • Richmmond Neurology
      • Spring Hill, Australia, QLD 4000
        • Associate Professor John O'Sullivan
  • Korea, Republic of
    • Anyang Gyeonggi-do
      • Dongan-gu, Anyang, Anyang Gyeonggi-do, Korea, Republic of
        • Hallym University Sacred Heart Hospital
    • Gyeonggi-Do
      • Uijeongbu Si, Gyeonggi-Do, Korea, Republic of
        • Uijeongbu St. Mary's Hospital
    • Seoul
      • Jongno-Gu, Seoul, Korea, Republic of
        • Kangbuk Samsung Hospital
      • Jongno-Gu, Seoul, Korea, Republic of
        • Seoul St. Mary's Hospital
      • Nowon-Gu, Seoul, Korea, Republic of
        • Seoul Eulji Hospital
      • Seodaemum-Gu, Seoul, Korea, Republic of
        • Yonsei University Dental Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255-7450
        • Arizona Neurological Institute
    • California
      • Encinitas, California, United States, 92024
        • The Research Center of Southern California, LLC
      • Los Angeles, California, United States, 90033
        • USC Neurology
      • San Francisco, California, United States, 94133
        • UCSF Headache Center
      • Santa Monica, California, United States, 90404
        • Neurological Research Institute
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Advanced Neurosciences Research, Llc
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute at Palm Beach Neurology
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Robbins Headache Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Mid-Atlantic Headache Institute
      • Largo, Maryland, United States, 20774
        • Kaiser Permanente Research Office/Neurology Department
    • Missouri
      • Springfield, Missouri, United States, 65807-6988
        • Clinvest Research
      • St. Louis, Missouri, United States, 63141
        • Mercy Health Research
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Institute for Neurosciences
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Headache Wellness Center
    • Ohio
      • Canton, Ohio, United States, 44718
        • Ohio Clinical Research Partners, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson University Hospitals
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Wesley Headache Clinic
    • Texas
      • Dallas, Texas, United States, 75231
        • Baylor Research Institute

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:

  • Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)

Exclusion Criteria:

  • Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis
  • Headache attributed to another disorder
  • Infection or skin disorder at injection sites
  • Previous treatment with botulinum toxin of any serotype for any reason
  • Anticipated need for botulinum toxin of any type for any reason during the course of the study
  • Previous participation in any botulinum toxin clinical trial

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BOTOX®
Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
Biological: onabotulinumtoxinA
Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
Other Names:
  • BOTOX®
  • botulinum toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Frequency of Headache Days
Time Frame: Baseline, Week 108
Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.
Baseline, Week 108

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Frequency of Headache Days
Time Frame: Baseline, Week 60
Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.
Baseline, Week 60
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
Time Frame: Baseline, Week 60, Week 108
The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.
Baseline, Week 60, Week 108

Collaborators and Investigators

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

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2011

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (ESTIMATE)

January 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2017

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-BTX-CM-10-001
  • The COMPEL Study (OTHER: Allergan, Inc)

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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