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
Verified date | April 2018 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
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 |
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