A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
NCT ID: NCT01516892
Last Updated: 2017-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
716 participants
INTERVENTIONAL
2011-12-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BOTOX®
Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
onabotulinumtoxinA
Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
Interventions
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onabotulinumtoxinA
Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 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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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
Associate Professor John O'Sullivan
Spring Hill, , Australia
Hallym University Sacred Heart Hospital
Dongan-gu, Anyang, Anyang Gyeonggi-do, South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Kangbuk Samsung Hospital
Jongno-Gu, Seoul, South Korea
Seoul St. Mary's Hospital
Jongno-Gu, Seoul, South Korea
Seoul Eulji Hospital
Nowon-Gu, Seoul, South Korea
Yonsei University Dental Hospital
Seodaemum-Gu, Seoul, South Korea
Countries
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References
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Blumenfeld AM, Tepper SJ, Robbins LD, Manack Adams A, Buse DC, Orejudos A, D Silberstein S. Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019 Mar;90(3):353-360. doi: 10.1136/jnnp-2018-319290. Epub 2019 Jan 10.
Blumenfeld AM, Stark RJ, Freeman MC, Orejudos A, Manack Adams A. Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018 Feb 5;19(1):13. doi: 10.1186/s10194-018-0840-8.
Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015 Jul 3;15:100. doi: 10.1186/s12883-015-0353-x.
Other Identifiers
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The COMPEL Study
Identifier Type: OTHER
Identifier Source: secondary_id
GMA-BTX-CM-10-001
Identifier Type: -
Identifier Source: org_study_id
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