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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01516892
Registration number
NCT01516892
Ethics application status
Date submitted
20/01/2012
Date registered
25/01/2012
Date last updated
6/01/2017
Titles & IDs
Public title
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
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Scientific title
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Secondary ID [1]
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The COMPEL Study
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Secondary ID [2]
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GMA-BTX-CM-10-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Migraine Disorders
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - onabotulinumtoxinA
Experimental: 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.
Treatment: Other: 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.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in the Frequency of Headache Days
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 108
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Secondary outcome [1]
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Change From Baseline in the Frequency of Headache Days
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Assessment method [1]
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Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. 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.
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Timepoint [1]
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Baseline, Week 60
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Secondary outcome [2]
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Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
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Assessment method [2]
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The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.
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Timepoint [2]
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Baseline, Week 60, Week 108
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Eligibility
Key inclusion criteria
* Diagnosis of chronic migraine (=15 days per month with headache lasting 4 hours a day or longer)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2015
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Sample size
Target
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Accrual to date
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Final
716
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Dr. Joseph Frasca - Adelaide
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Recruitment hospital [2]
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Dr. Con Yiannikas - Burwood
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Recruitment hospital [3]
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Associate Professor Richard Stark - Melbourne
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Recruitment hospital [4]
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Richmmond Neurology - Richmond
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Recruitment hospital [5]
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Associate Professor John O'Sullivan - Spring Hill
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Recruitment postcode(s) [1]
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SA 5000 - Adelaide
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Recruitment postcode(s) [2]
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NSW 2134 - Burwood
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VIC 3000 - Melbourne
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Recruitment postcode(s) [4]
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VIC 3051 - Richmond
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Recruitment postcode(s) [5]
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QLD 4000 - Spring Hill
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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Florida
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Illinois
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Maryland
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Missouri
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Nevada
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New York
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North Carolina
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Ohio
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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Country [15]
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Korea, Republic of
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Anyang Gyeonggi-do
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Country [16]
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01516892
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Allergan
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01516892
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