A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

August 3, 2017 updated by: Allergan

191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine

To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 3

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Fullerton, California, United States, 92835
        • Fullerton Neurology and Headache Center
      • Oceanside, California, United States, 92056
        • The Research Center of Southern California
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern CT, P.C.
      • Stamford, Connecticut, United States, 06905
        • New England Institute for Clinical Research
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • NW FL Clinical Research Group, LLC
      • Orlando, Florida, United States, 32819
        • Pediatric Neurology, PA
      • West Palm Beach, Florida, United States, 33407
        • The Premiere Research Institute at Palm Beach Neurology
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Josephson Wallack Munshower Neurology, P.C.
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • CPFCC Neurology Research Department
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain & Neurological Institute
    • Missouri
      • Springfield, Missouri, United States, 65804
        • CORE (Center for Outpatient Research)
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Institution for Neurosciences
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Jill Waldo, CCRC
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Neuroscience Group
    • Texas
      • San Antonio, Texas, United States, 78258
        • Texas Association of Pediatric Neurology/Road Runner Research
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research

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

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical history of chronic migraine for at least 6 months
  • 15 or more headache days during a 4 week period

Exclusion Criteria:

  • Previous use of any botulinum toxin of any serotype for any reason
  • Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
  • Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit
  • Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Biological: Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Experimental: Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Biological: Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Placebo Comparator: Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
Drug: Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.

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, 12 Weeks
Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.
Baseline, 12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Frequency of Severe Headache Days
Time Frame: Baseline, 12 Weeks
Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.
Baseline, 12 Weeks
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days
Time Frame: Baseline, 12 Weeks
Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.
Baseline, 12 Weeks
Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Time Frame: Baseline, 12 Weeks
Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.
Baseline, 12 Weeks
Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment
Time Frame: 12 Weeks
Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.
12 Weeks

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

Helpful Links

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

October 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 8, 2012

First Posted (Estimate)

August 10, 2012

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-103

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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