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This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Dysphagia | Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing. | 64 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Intractable Migraine | Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away. | 64 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Chronic Migraine
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Munich | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28758415 | Background | Matharu M, Pascual J, Nilsson Remahl I, Straube A, Lum A, Davar G, Odom D, Bennett L, Proctor C, Gutierrez L, Andrews E, Johannes C. Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Cephalalgia. 2017 Dec;37(14):1384-1397. doi: 10.1177/0333102417724150. Epub 2017 Jul 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Treated Population includes all patients who received at least 1 dose of botulinum toxin Type A and is used for baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence Rate of Dysphagia | Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing. | Treated Population: all patients who received at least 1 dose of botulinum toxin Type A | Posted | Number | 95% Confidence Interval | events per 1,000 person-months | 64 weeks |
|
|
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The Treated Population includes all patients who received at least 1 dose of botulinum toxin Type A and is used to assess adverse events and serious adverse events.
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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 | Botulinum Toxin Type A | 155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Oviedo |
| Spain |
| Stockholm | Sweden |
| London | United Kingdom |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Incidence Rate of Intractable Migraine | Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away. | Treated Population: all patients who received at least 1 dose of botulinum toxin Type A | Posted | Number | 95% Confidence Interval | events per 1,000 person-months | 64 weeks |
|
|
|
| 61 |
| 1,160 |
| 106 |
| 1,160 |
| Angina pectoris | Cardiac disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA version 13.1 | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 13.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 13.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
|
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
|
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 13.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Hemiplegic migraine | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA version 13.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 13.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Breast haematoma | Reproductive system and breast disorders | MedDRA version 13.1 | Non-systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA version 13.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D009422 | Nervous System Diseases |
| 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 |