Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

May 7, 2018 updated by: Allergan

A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of BOTOX® and Topiramate for Headache Prophylaxis in Adults With Chronic Migraine

This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

282

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St Joseph's Hospital Barrow Neurology Clinics
    • California
      • Encinitas, California, United States, 92024
        • North County Neurology Associates
      • Fresno, California, United States, 93723
        • California Headache and Balance Center
      • Newport Beach, California, United States, 92663
        • Newport Beach Clinical Research Associates, Inc.
    • Colorado
      • Denver, Colorado, United States, 80210
        • Denver Neurological Clinic
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Ki Health Partners LLC DBA New England Institute for Neurology and Headache
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
      • Doral, Florida, United States, 33172
        • Design Neuroscience Center
      • Gulf Breeze, Florida, United States, 32561
        • NW FL Clinical Research Group, LLC
      • Sarasota, Florida, United States, 34239
        • Negroski, Sutherland & Hanes Neurology
      • West Palm Beach, Florida, United States, 33407
        • Neurology Research Institute at Palm Beach Neurology
    • Illinois
      • Riverwoods, Illinois, United States, 60015
        • Robbins Headache Clinic
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • International Clinical Research Institute Inc
      • Overland Park, Kansas, United States, 66211
        • Kansas City Bone and Joint Clinic
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70810
        • The Neuromedical Center
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • MedVadis Research Corporation
      • Worcester, Massachusetts, United States, 01605
        • New England Regional Headache Center Inc
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Health Research
      • Springfield, Missouri, United States, 65807
        • Clinvest
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Institute for Neurosciences
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center Incorporated
      • Bronx, New York, United States, 10461
        • Montefiore Headache Center
      • Plainview, New York, United States, 11803
        • Island Neurological Associates PC
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Asheville Neurology Specialists PA
      • Greensboro, North Carolina, United States, 27405
        • Headache Wellness Center
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health Lankenau Hospital
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology
    • Washington
      • Tacoma, Washington, United States, 98409
        • Puget Sound Neurology

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of chronic migraine
  • More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).

Exclusion Criteria:

  • Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
  • Previous treatment with botulinum toxin of any serotype for any reason
  • Previous treatment with topiramate
  • On a ketogenic diet (high in fat, low in carbohydrates)
  • History of acute myopia or increased intraocular pressure
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
  • Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BOTOX®
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
Biological: onabotulinumtoxinA
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Active Comparator: Topiramate
Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®.
Drug: Topiramate
Topiramate up to a maximum oral dose of 100 mg/day.
Other Names:
  • Topamax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Time Frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.
Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Frequency of Headache Days Per 28-day Period
Time Frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. A negative change from Baseline (less headache days) indicates improvement.
Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Change From Baseline in Headache Impact Test (HIT-6) Total Score
Time Frame: Baseline (Day 1) to the last 28-day period ending with Week 30

The HIT-6 is a valid disease-targeted measure used to assess the impact of headaches, comprised of 6 items that assess pain, role functioning, social functioning, cognitive functioning, vitality, and psychological distress. A total score is created by summingacross all items, and ranges from 36 (no impact) to 78 (severe impact) reflecting a "best to worst" scoring.

A negative change from Baseline (a lower score) indicates improvement.
Baseline (Day 1) to the last 28-day period ending with Week 30
Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days
Time Frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 70% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.
Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32

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 (Actual)

August 5, 2014

Primary Completion (Actual)

May 9, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

June 7, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-US-NEU-0206
  • FORWARD (Allergan)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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