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

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
onabotulinumtoxinA
Topiramate
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Joseph's Hospital Barrow Neurology Clinics
  • North County Neurology Associates
  • California Headache and Balance Center
  • Newport Beach Clinical Research Associates, Inc.
  • Denver Neurological Clinic
  • Ki Health Partners LLC DBA New England Institute for Neurology and Headache
  • Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
  • Design Neuroscience Center
  • NW FL Clinical Research Group, LLC
  • Negroski, Sutherland & Hanes Neurology
  • Neurology Research Institute at Palm Beach Neurology
  • Robbins Headache Clinic
  • International Clinical Research Institute Inc
  • Kansas City Bone and Joint Clinic
  • The NeuroMedical Center
  • MedVadis Research Corporation
  • New England Regional Headache Center Inc
  • Allegiance Health
  • Mercy Health Research
  • Clinvest
  • Renown Institute for Neurosciences
  • Dent Neurosciences Research Center Incorporated
  • Montefiore Headache Center
  • Island Neurological Associates PC
  • Asheville Neurology Specialists PA
  • Headache Wellness Center
  • Raleigh Neurology Associates PA
  • Thomas Jefferson University
  • Preferred Primary Care Physicians
  • Main Line Health Lankenau Hospital
  • Texas Neurology
  • Puget Sound Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

BOTOX®

Topiramate

Arm Description

155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.

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®.

Outcomes

Primary Outcome Measures

Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
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.

Secondary Outcome Measures

Change From Baseline in the Frequency of Headache Days Per 28-day Period
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.
Change From Baseline in Headache Impact Test (HIT-6) Total Score
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.
Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days
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.

Full Information

First Posted
July 14, 2014
Last Updated
May 7, 2018
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02191579
Brief Title
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 5, 2014 (Actual)
Primary Completion Date
May 9, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BOTOX®
Arm Type
Active Comparator
Arm Description
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
Arm Title
Topiramate
Arm Type
Active Comparator
Arm Description
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®.
Intervention Type
Biological
Intervention Name(s)
onabotulinumtoxinA
Other Intervention Name(s)
BOTOX®, botulinum toxin Type A
Intervention Description
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
Topamax®
Intervention Description
Topiramate up to a maximum oral dose of 100 mg/day.
Primary Outcome Measure Information:
Title
Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Description
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.
Time Frame
Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Secondary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Headache Days Per 28-day Period
Description
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.
Time Frame
Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Title
Change From Baseline in Headache Impact Test (HIT-6) Total Score
Description
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.
Time Frame
Baseline (Day 1) to the last 28-day period ending with Week 30
Title
Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days
Description
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.
Time Frame
Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Jo
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
St Joseph's Hospital Barrow Neurology Clinics
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
North County Neurology Associates
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
California Headache and Balance Center
City
Fresno
State/Province
California
ZIP/Postal Code
93723
Country
United States
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Denver Neurological Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Ki Health Partners LLC DBA New England Institute for Neurology and Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Design Neuroscience Center
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
NW FL Clinical Research Group, LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Negroski, Sutherland & Hanes Neurology
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Neurology Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Robbins Headache Clinic
City
Riverwoods
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Facility Name
International Clinical Research Institute Inc
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Kansas City Bone and Joint Clinic
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
The NeuroMedical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
MedVadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
New England Regional Headache Center Inc
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Renown Institute for Neurosciences
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Dent Neurosciences Research Center Incorporated
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Montefiore Headache Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Island Neurological Associates PC
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Asheville Neurology Specialists PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Raleigh Neurology Associates PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Main Line Health Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Texas Neurology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Puget Sound Neurology
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98409
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32985341
Citation
Blumenfeld AM, Patel AT, Turner IM, Mullin KB, Manack Adams A, Rothrock JF. Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720959936. doi: 10.1177/2150132720959936.
Results Reference
derived
PubMed Identifier
31559634
Citation
Rothrock JF, Adams AM, Lipton RB, Silberstein SD, Jo E, Zhao X, Blumenfeld AM; FORWARD Study investigative group. FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. Headache. 2019 Nov;59(10):1700-1713. doi: 10.1111/head.13653. Epub 2019 Sep 26.
Results Reference
derived

Learn more about this trial

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

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