Migraine DisordersPhase 4NCT01516892
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
A Phase 4 study testing onabotulinumtoxinA in people with Migraine Disorders, run by Allergan at 32 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- onabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 716 participants
- Where
- 32 sitesin 3 countries
- Study dates
- Dec 2011to Nov 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
Who cannot join
- 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
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States21 sites
Dent Neurologic Institute
Amherst, New York, 14226
Mid-Atlantic Headache Institute
Baltimore, Maryland, 21208
Ohio Clinical Research Partners, LLC
Canton, Ohio, 44718
Wesley Headache Clinic
Cordova, Tennessee, 38018
Baylor Research Institute
Dallas, Texas, 75231
The Research Center of Southern California, LLC
Encinitas, California, 92024
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528
Headache Wellness Center
Greensboro, North Carolina, 27405
Kaiser Permanente Research Office/Neurology Department
Largo, Maryland, 20774
USC Neurology
Los Angeles, California, 90033
Robbins Headache Clinic
Northbrook, Illinois, 60062
Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
Renown Institute for Neurosciences
Reno, Nevada, 89502
UCSF Headache Center
San Francisco, California, 94133
Neurological Research Institute
Santa Monica, California, 90404
Arizona Neurological Institute
Scottsdale, Arizona, 85255-7450
Clinvest Research
Springfield, Missouri, 65807-6988
Mercy Health Research
St Louis, Missouri, 63141
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10461
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
South Korea6 sites
Hallym University Sacred Heart Hospital
Dongan-gu, Anyang, Anyang Gyeonggi-do
Kangbuk Samsung Hospital
Jongno-Gu, Seoul
Seoul St. Mary's Hospital
Jongno-Gu, Seoul
Seoul Eulji Hospital
Nowon-Gu, Seoul
Yonsei University Dental Hospital
Seodaemum-Gu, Seoul
Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do
Australia5 sites
Dr. Joseph Frasca
Adelaide, SA 5000
Dr. Con Yiannikas
Burwood, NSW 2134
Associate Professor Richard Stark
Melbourne, VIC 3000
Richmmond Neurology
Richmond, VIC 3051
Associate Professor John O'Sullivan
Spring Hill, QLD 4000
About this study
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.
- Conditions
- Migraine Disorders
- Being tested
- onabotulinumtoxinA
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinABiological
Also called BOTOX®, botulinum toxin Type A
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.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Experimental | 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. Receives: Biological: onabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 108
Secondary outcomes (2)
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 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.
Measured: Baseline, Week 60
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
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.
Measured: Baseline, Week 60, Week 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516892
- Sponsor's protocol ID
- GMA-BTX-CM-10-001
- Other IDs
- The COMPEL Study
- Status last verified
- Nov 2016
- First submitted
- 20 Jan 2012
- Last updated
- 6 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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. 2026 May;66(5):1069-1080. doi: 10.1111/head.70007. Epub 2025 Dec 15.
PubMed 41393002Blumenfeld 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.
PubMed 30630956Blumenfeld 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.
PubMed 29404713Blumenfeld 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.
PubMed 26133547
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
- ClinicalTrials.gov ID
- NCT01516892
- Acronym / sponsor ID
- GMA-BTX-CM-10-001
- Conditions
- Migraine Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 716 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Posted 6 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | Experimental | Biological: onabotulinumtoxinAParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| onabotulinumtoxinAAlso: BOTOX®, botulinum toxin Type AParticipants 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. | Biological | BOTOX® |
Primary outcome
Change From Baseline in the Frequency of Headache Days
Time frame: Baseline, Week 108
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.
2 secondary outcomes
Change From Baseline in the Frequency of Headache Days
Time frame: Baseline, Week 60
Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score
Time frame: Baseline, Week 60, Week 108
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41393002Blumenfeld 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. 2026 May;66(5):1069-1080. doi: 10.1111/head.70007. Epub 2025 Dec 15.
- Derived from this study: PubMed 30630956Blumenfeld 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.
- Derived from this study: PubMed 29404713Blumenfeld 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.
- Derived from this study: PubMed 26133547Blumenfeld 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing onabotulinumtoxinA in people with Migraine Disorders, run by Allergan at 32 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Frequency of Headache Days (time frame: Baseline, Week 108). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01516892, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.