A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine

Completed · Phase 4

Conditions studied: Migraine Disorders

In brief

This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.

Key facts

Study ID

NCT01516892

Run by

Allergan

People needed

716

Starts

2011-12-01

Expected to finish

2015-11-01

Last updated by the study team

2017-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)

You may not qualify if…

• Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis
• Headache attributed to another disorder
• Infection or skin disorder at injection sites
• Previous treatment with botulinum toxin of any serotype for any reason
• Anticipated need for botulinum toxin of any type for any reason during the course of the study
• Previous participation in any botulinum toxin clinical trial

Where it is running

• Arizona Neurological Institute — Scottsdale, Arizona, United States
• The Research Center of Southern California, LLC — Encinitas, California, United States
• USC Neurology — Los Angeles, California, United States
• UCSF Headache Center — San Francisco, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Advanced Neurosciences Research, LLC — Fort Collins, Colorado, United States
• Tampa General Hospital — Tampa, Florida, United States
• Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States
• Robbins Headache Clinic — Northbrook, Illinois, United States
• Mid-Atlantic Headache Institute — Baltimore, Maryland, United States
• Kaiser Permanente Research Office/Neurology Department — Largo, Maryland, United States
• Clinvest Research — Springfield, Missouri, United States
• Mercy Health Research — St Louis, Missouri, United States
• Renown Institute for Neurosciences — Reno, Nevada, United States
• Dent Neurologic Institute — Amherst, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Headache Wellness Center — Greensboro, North Carolina, United States
• Ohio Clinical Research Partners, LLC — Canton, Ohio, United States
• Jefferson University Hospitals — Philadelphia, Pennsylvania, United States
• Wesley Headache Clinic — Cordova, Tennessee, United States
• Baylor Research Institute — Dallas, Texas, United States
• Dr. Joseph Frasca — Adelaide, Australia
• Dr. Con Yiannikas — Burwood, Australia
• Associate Professor Richard Stark — Melbourne, Australia
• Richmmond Neurology — Richmond, Australia

Full record on ClinicalTrials.gov

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