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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191579
• Other study ID #: GMA-US-NEU-0206
• Secondary ID: FORWARD
• Status: Completed
• Phase: Phase 4
• Start date: August 5, 2014
• Est. completion date: September 1, 2017

Study information

• Verified date: April 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: September 1, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Biological:
• onabotulinumtoxinA
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.

Drug:
• Topiramate
Topiramate up to a maximum oral dose of 100 mg/day.

Locations

Country	Name	City	State
United States	Dent Neurosciences Research Center Incorporated	Amherst	New York
United States	Asheville Neurology Specialists PA	Asheville	North Carolina
United States	The NeuroMedical Center	Baton Rouge	Louisiana
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton Inc	Boca Raton	Florida
United States	Montefiore Headache Center	Bronx	New York
United States	Texas Neurology	Dallas	Texas
United States	Denver Neurological Clinic	Denver	Colorado
United States	Design Neuroscience Center	Doral	Florida
United States	North County Neurology Associates	Encinitas	California
United States	California Headache and Balance Center	Fresno	California
United States	Headache Wellness Center	Greensboro	North Carolina
United States	NW FL Clinical Research Group, LLC	Gulf Breeze	Florida
United States	Allegiance Health	Jackson	Michigan
United States	Newport Beach Clinical Research Associates, Inc.	Newport Beach	California
United States	International Clinical Research Institute Inc	Overland Park	Kansas
United States	Kansas City Bone and Joint Clinic	Overland Park	Kansas
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	St Joseph's Hospital Barrow Neurology Clinics	Phoenix	Arizona
United States	Preferred Primary Care Physicians	Pittsburgh	Pennsylvania
United States	Island Neurological Associates PC	Plainview	New York
United States	Raleigh Neurology Associates PA	Raleigh	North Carolina
United States	Renown Institute for Neurosciences	Reno	Nevada
United States	Robbins Headache Clinic	Riverwoods	Illinois
United States	Mercy Health Research	Saint Louis	Missouri
United States	Negroski, Sutherland & Hanes Neurology	Sarasota	Florida
United States	Clinvest	Springfield	Missouri
United States	Ki Health Partners LLC DBA New England Institute for Neurology and Headache	Stamford	Connecticut
United States	Puget Sound Neurology	Tacoma	Washington
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	Neurology Research Institute at Palm Beach Neurology	West Palm Beach	Florida
United States	New England Regional Headache Center Inc	Worcester	Massachusetts
United States	Main Line Health Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Secondary	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.	Baseline (Day 1) to the last 28-day period ending with Week 30
Secondary	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.	Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32