A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine Disorders

In brief

To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.

Key facts

Study ID

NCT01662492

Run by

Allergan

People needed

125

Starts

2012-10-01

Expected to finish

2016-08-01

Last updated by the study team

2017-09-05

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medical history of chronic migraine for at least 6 months
• 15 or more headache days during a 4 week period

You may not qualify if…

• Previous use of any botulinum toxin of any serotype for any reason
• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
• Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit
• Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Fullerton Neurology and Headache Center — Fullerton, California, United States
• The Research Center of Southern California — Oceanside, California, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Associated Neurologists of Southern CT, P.C. — Fairfield, Connecticut, United States
• New England Institute for Clinical Research — Stamford, Connecticut, United States
• NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States
• Pediatric Neurology, PA — Orlando, Florida, United States
• The Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• Josephson Wallack Munshower Neurology, P.C. — Indianapolis, Indiana, United States
• CPFCC Neurology Research Department — Overland Park, Kansas, United States
• Michigan Head Pain & Neurological Institute — Ann Arbor, Michigan, United States
• CORE (Center for Outpatient Research) — Springfield, Missouri, United States
• Renown Institution for Neurosciences — Reno, Nevada, United States
• Rochester Clinical Research, Inc — Rochester, New York, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Jill Waldo, CCRC — Pittsburgh, Pennsylvania, United States
• Nashville Neuroscience Group — Nashville, Tennessee, United States
• Texas Association of Pediatric Neurology/Road Runner Research — San Antonio, Texas, United States
• Wasatch Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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