Clinical trial NCT01516892: A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 716
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)

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

Primary outcomes:
measure: Change From Baseline in the Frequency of Headache Days
timeFrame: Baseline, Week 108
Secondary outcomes:
measure: Change From Baseline in the Frequency of Headache Days
timeFrame: Baseline, Week 60
measure: Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
timeFrame: Baseline, Week 60, Week 108
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Neurological Institute
state: Arizona
city: Encinitas
country: United States
facility: The Research Center of Southern California, LLC
state: California
city: Los Angeles
country: United States
facility: USC Neurology
state: California
city: San Francisco
country: United States
facility: UCSF Headache Center
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC
state: Colorado
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Northbrook
country: United States
facility: Robbins Headache Clinic
state: Illinois
city: Baltimore
country: United States
facility: Mid-Atlantic Headache Institute
state: Maryland
city: Largo
country: United States
facility: Kaiser Permanente Research Office/Neurology Department
state: Maryland
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Reno
country: United States
facility: Renown Institute for Neurosciences
state: Nevada
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Canton
country: United States
facility: Ohio Clinical Research Partners, LLC
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson University Hospitals
state: Pennsylvania
city: Cordova
country: United States
facility: Wesley Headache Clinic
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Adelaide
country: Australia
facility: Dr. Joseph Frasca
city: Burwood
country: Australia
facility: Dr. Con Yiannikas
city: Melbourne
country: Australia
facility: Associate Professor Richard Stark
city: Richmond
country: Australia
facility: Richmmond Neurology
city: Spring Hill
country: Australia
facility: Associate Professor John O'Sullivan
city: Dongan-gu, Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Anyang Gyeonggi-do
city: Uijeongbu Si
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
state: Gyeonggi-Do
city: Jongno-Gu
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Seoul
city: Jongno-Gu
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seoul
city: Nowon-Gu
country: Korea, Republic of
facility: Seoul Eulji Hospital
state: Seoul
city: Seodaemum-Gu
country: Korea, Republic of
facility: Yonsei University Dental Hospital
state: Seoul
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.