A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
2 other identifiers
interventional
716
3 countries
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2011
Longer than P75 for phase_4
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
January 6, 2017
CompletedJanuary 6, 2017
November 1, 2016
3.9 years
January 20, 2012
November 9, 2016
November 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Frequency of Headache Days
Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.
Baseline, Week 108
Secondary Outcomes (2)
Change From Baseline in the Frequency of Headache Days
Baseline, Week 60
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
Baseline, Week 60, Week 108
Study Arms (1)
BOTOX®
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (32)
Arizona Neurological Institute
Scottsdale, Arizona, 85255-7450, United States
The Research Center of Southern California, LLC
Encinitas, California, 92024, United States
USC Neurology
Los Angeles, California, 90033, United States
UCSF Headache Center
San Francisco, California, 94133, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Robbins Headache Clinic
Northbrook, Illinois, 60062, United States
Mid-Atlantic Headache Institute
Baltimore, Maryland, 21208, United States
Kaiser Permanente Research Office/Neurology Department
Largo, Maryland, 20774, United States
Clinvest Research
Springfield, Missouri, 65807-6988, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Renown Institute for Neurosciences
Reno, Nevada, 89502, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
Ohio Clinical Research Partners, LLC
Canton, Ohio, 44718, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107, United States
Wesley Headache Clinic
Cordova, Tennessee, 38018, United States
Baylor Research Institute
Dallas, Texas, 75231, United States
Dr. Joseph Frasca
Adelaide, SA 5000, Australia
Dr. Con Yiannikas
Burwood, NSW 2134, Australia
Associate Professor Richard Stark
Melbourne, VIC 3000, Australia
Richmmond Neurology
Richmond, VIC 3051, Australia
Associate Professor John O'Sullivan
Spring Hill, QLD 4000, 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
Related Publications (4)
Blumenfeld AM, Charleston L 4th, Kuruvilla D, Savage-Edwards B, Lipton RB, Singh R, Jacob P, Lawrence NA, Wang C, O'Brien HL. OnabotulinumtoxinA treatment among diverse racial groups: Post hoc analysis of the phase 4 Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) trial. Headache. 2025 Dec 15. doi: 10.1111/head.70007. Online ahead of print.
PMID: 41393002DERIVEDBlumenfeld 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.
PMID: 30630956DERIVEDBlumenfeld 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.
PMID: 29404713DERIVEDBlumenfeld 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.
PMID: 26133547DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2012
First Posted
January 25, 2012
Study Start
December 1, 2011
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
January 6, 2017
Results First Posted
January 6, 2017
Record last verified: 2016-11