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This post marketing surveillance study in Korea will evaluate the safety and efficacy of BOTOX (botulinum toxin Type A) in patients who receive treatment according to standard of care for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axillary Hyperhidrosis | Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
| |
| Focal Spasticity | Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
| |
| Glabellar Lines | Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin Type A | Biological | Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event. | 4 Years |
| Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale | Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement. | Pre-dose (Baseline), Post-dose (Up to 4 Years) |
| Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale | The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement. | Pre-dose (Baseline), Post-dose (Up to 4 Years) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
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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 | Axillary Hyperhidrosis | Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
| FG001 | Focal Spasticity | Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
| FG002 | Glabellar Lines | Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline measures were based on the Safety population that included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Axillary Hyperhidrosis | Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
| BG001 | Focal Spasticity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) | An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event. | Safety population included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded. | Posted | Number | participants | 4 Years |
|
Adverse Events were collected for Up to 4 Years
Safety population, all participants treated with BOTOX® as prescribed excluding participants previously treated with survey drug (BOTOX®), was used to assess the number of participants at risk for 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 | Axillary Hyperhidrosis | Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President GSE, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009135 | Muscular 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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| Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale | The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement. | Pre-dose (Baseline), Post-dose (Up to 4 Years) |
Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
| BG002 | Glabellar Lines | Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
| OG001 | Focal Spasticity | Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
| OG002 | Glabellar Lines | Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. |
|
|
| Primary | Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale | Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement. | Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded. | Posted | Mean | Standard Deviation | score on a scale | Pre-dose (Baseline), Post-dose (Up to 4 Years) |
|
|
|
| Primary | Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale | The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement. | Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded. | Posted | Mean | Standard Deviation | score on a scale | Pre-dose (Baseline), Post-dose (Up to 4 Years) |
|
|
|
| Primary | Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale | The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement. | Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded. | Posted | Mean | Standard Deviation | score on a scale | Pre-dose (Baseline), Post-dose (Up to 4 Years) |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Focal Spasticity | Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. | 0 | 237 | 0 | 237 |
| EG002 | Glabellar Lines | Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice. | 0 | 423 | 0 | 423 |
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.
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |