Clinical trial NCT02191579: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
timeFrame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Secondary outcomes:
measure: Change From Baseline in the Frequency of Headache Days Per 28-day Period
timeFrame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
measure: Change From Baseline in Headache Impact Test (HIT-6) Total Score
timeFrame: Baseline (Day 1) to the last 28-day period ending with Week 30
measure: Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days
timeFrame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St Joseph's Hospital Barrow Neurology Clinics
state: Arizona
city: Encinitas
country: United States
facility: North County Neurology Associates
state: California
city: Fresno
country: United States
facility: California Headache and Balance Center
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Denver
country: United States
facility: Denver Neurological Clinic
state: Colorado
city: Stamford
country: United States
facility: Ki Health Partners LLC DBA New England Institute for Neurology and Headache
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
state: Florida
city: Doral
country: United States
facility: Design Neuroscience Center
state: Florida
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group, LLC
state: Florida
city: Sarasota
country: United States
facility: Negroski, Sutherland & Hanes Neurology
state: Florida
city: West Palm Beach
country: United States
facility: Neurology Research Institute at Palm Beach Neurology
state: Florida
city: Riverwoods
country: United States
facility: Robbins Headache Clinic
state: Illinois
city: Overland Park
country: United States
facility: International Clinical Research Institute Inc
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Bone and Joint Clinic
state: Kansas
city: Baton Rouge
country: United States
facility: The NeuroMedical Center
state: Louisiana
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Worcester
country: United States
facility: New England Regional Headache Center Inc
state: Massachusetts
city: Jackson
country: United States
facility: Allegiance Health
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Reno
country: United States
facility: Renown Institute for Neurosciences
state: Nevada
city: Amherst
country: United States
facility: Dent Neurosciences Research Center Incorporated
state: New York
city: Bronx
country: United States
facility: Montefiore Headache Center
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates PC
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists PA
state: North Carolina
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates PA
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Lankenau Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Neurology
state: Texas
city: Tacoma
country: United States
facility: Puget Sound Neurology
state: Washington
Study officials:
affiliation: Allergan
name: Esther Jo
role: STUDY_DIRECTOR
References:
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.
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.