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This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin Type A | Experimental | Botulinum toxin Type A injected across specific head and neck muscles on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | Botulinum toxin Type A injected across specific head and neck muscles on Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Adverse Events | An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score | The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening. | Baseline, Day 28 |
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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 |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | Botulinum toxin Type A injected across specific head and neck muscles on Day 0. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Population included patients enrolled in the study who received study drug. The Safety Population was used to assess the baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | Botulinum toxin Type A injected across specific head and neck muscles on Day 0. |
| 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 | Percentage of Patients With Adverse Events | An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | Safety Population: patients enrolled in the study who received study drug | Posted | Number | Percentage of Patients | 28 Days |
|
|
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The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs). The Safety Population included patients enrolled in the study who received study drug.
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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 | Botulinum toxin Type A injected across specific head and neck muscles on Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | WHO-ART 092 | 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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| Physician Global Assessment of Outcome on a 3-Point Scale | Physicians evaluated patient migraines as improved, no change, or worse compared to baseline. | Baseline, Day 28 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score | The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening. | Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Day 28 |
|
|
|
| Secondary | Physician Global Assessment of Outcome on a 3-Point Scale | Physicians evaluated patient migraines as improved, no change, or worse compared to baseline. | Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment | Posted | Number | Patients | Baseline, Day 28 |
|
|
|
| 4 |
| 279 |
| 38 |
| 279 |
| Fever | General disorders | WHO-ART 092 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
|
| Common Cold | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| Ptosis | Nervous system disorders | WHO-ART 092 | Non-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 |
|