A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
NCT ID: NCT01662492
Last Updated: 2017-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
125 participants
INTERVENTIONAL
2012-10-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
Interventions
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Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 15 or more headache days during a 4 week period
Exclusion Criteria
* 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
12 Years
17 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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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
Countries
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References
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Shah S, Calderon MD, Wu W, Grant J, Rinehart J. Onabotulinumtoxin A (BOTOX(R)) for ProphylaCTIC Treatment of Pediatric Migraine: A Retrospective Longitudinal Analysis. J Child Neurol. 2018 Aug;33(9):580-586. doi: 10.1177/0883073818776142. Epub 2018 Jun 7.
Related Links
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More Information
Other Identifiers
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191622-103
Identifier Type: -
Identifier Source: org_study_id
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