Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
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
2 other identifiers
interventional
282
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2014
Typical duration for phase_4
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedStudy Start
First participant enrolled
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
June 7, 2018
CompletedJune 7, 2018
April 1, 2018
2.8 years
July 14, 2014
May 7, 2018
May 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Secondary Outcomes (3)
Change From Baseline in the Frequency of Headache Days Per 28-day Period
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
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
Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Study Arms (2)
BOTOX®
ACTIVE COMPARATOR155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
Topiramate
ACTIVE COMPARATORTopiramate 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®.
Interventions
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (32)
St Joseph's Hospital Barrow Neurology Clinics
Phoenix, Arizona, 85013, United States
North County Neurology Associates
Encinitas, California, 92024, United States
California Headache and Balance Center
Fresno, California, 93723, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663, United States
Denver Neurological Clinic
Denver, Colorado, 80210, United States
Ki Health Partners LLC DBA New England Institute for Neurology and Headache
Stamford, Connecticut, 06905, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
Boca Raton, Florida, 33486, United States
Design Neuroscience Center
Doral, Florida, 33172, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561, United States
Negroski, Sutherland & Hanes Neurology
Sarasota, Florida, 34239, United States
Neurology Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Robbins Headache Clinic
Riverwoods, Illinois, 60015, United States
International Clinical Research Institute Inc
Overland Park, Kansas, 66210, United States
Kansas City Bone and Joint Clinic
Overland Park, Kansas, 66211, United States
The NeuroMedical Center
Baton Rouge, Louisiana, 70810, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
New England Regional Headache Center Inc
Worcester, Massachusetts, 01605, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Clinvest
Springfield, Missouri, 65807, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Renown Institute for Neurosciences
Reno, Nevada, 89502, United States
Dent Neurosciences Research Center Incorporated
Amherst, New York, 14226, United States
Island Neurological Associates PC
Plainview, New York, 11803, United States
Montefiore Headache Center
The Bronx, New York, 10461, United States
Asheville Neurology Specialists PA
Asheville, North Carolina, 28806, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
Raleigh Neurology Associates PA
Raleigh, North Carolina, 27607, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236, United States
Main Line Health Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Texas Neurology
Dallas, Texas, 75214, United States
Puget Sound Neurology
Tacoma, Washington, 98409, United States
Related Publications (2)
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.
PMID: 32985341DERIVEDRothrock 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.
PMID: 31559634DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Esther Jo
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 16, 2014
Study Start
August 5, 2014
Primary Completion
May 9, 2017
Study Completion
September 1, 2017
Last Updated
June 7, 2018
Results First Posted
June 7, 2018
Record last verified: 2018-04