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| ID | Type | Description | Link |
|---|---|---|---|
| The COMPEL Study | Other Identifier | Allergan, Inc |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Neurological Institute | Scottsdale | Arizona | 85255-7450 | United States | ||
| The Research Center of Southern California, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41393002 | Derived | 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. | |
| 30630956 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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. | Baseline, Week 60, Week 108 |
| 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 |
| Derived |
| 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. |
| 29404713 | Derived | 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. |
| 26133547 | Derived | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit. | Posted | Mean | Standard Deviation | headache days | Baseline, Week 108 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit. | Posted | Mean | Standard Deviation | headache days | Baseline, Week 60 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants from the Analysis Population, all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit, with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 60, Week 108 |
|
|
108 Weeks
Safety population included all participants who received at least one BOTOX® treatment injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 75 | 716 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic valve incompetence | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cushing's syndrome | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Device intolerance | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angiomyolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Mantle cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic hyperosmolar coma | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
A disclosure restriction on the PI is that results publication or presentations be submitted for sponsor review no less than 90 days in advance, during which the sponsor can embargo such communications prior to public release. The embargo may be extended for up to 90 days for the sponsor to preserve its proprietary rights. PI will not publish study results prior to release of a multicenter manuscript including data from all study centers. The sponsor cannot require changes to the communication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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|
|