Trial Outcomes & Findings for Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea (NCT NCT02043145)
NCT ID: NCT02043145
Last Updated: 2014-06-13
Results Overview
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.
COMPLETED
727 participants
4 Years
2014-06-13
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
247
|
425
|
|
Overall Study
COMPLETED
|
55
|
247
|
425
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea
Baseline characteristics by cohort
| Measure |
Axillary Hyperhidrosis
n=55 Participants
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
n=237 Participants
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
n=423 Participants
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.
|
Total
n=715 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 30 years
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Age, Customized
30 to 39 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Age, Customized
40 to 49 years
|
6 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Age, Customized
>=50 years
|
4 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
376 Participants
n=5 Participants
|
502 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
213 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 YearsPopulation: Safety population included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded.
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.
Outcome measures
| Measure |
Axillary Hyperhidrosis
n=55 Participants
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
n=237 Participants
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
n=423 Participants
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.
|
|---|---|---|---|
|
Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)
Serious Adverse Drug Reactions
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)
Adverse Events
|
0 participants
|
6 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Pre-dose (Baseline), Post-dose (Up to 4 Years)Population: 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.
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.
Outcome measures
| Measure |
Axillary Hyperhidrosis
n=54 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale
Pre-dose (Baseline)
|
2.93 score on a scale
Standard Deviation 0.72
|
—
|
—
|
|
Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale
Change from Baseline at Post-dose
|
-1.61 score on a scale
Standard Deviation 0.79
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (Baseline), Post-dose (Up to 4 Years)Population: 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.
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.
Outcome measures
| Measure |
Axillary Hyperhidrosis
n=167 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale
Pre-dose (Baseline)
|
2.85 score on a scale
Standard Deviation 0.73
|
—
|
—
|
|
Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale
Change from Baseline at Post-dose
|
-1.22 score on a scale
Standard Deviation 0.64
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (Baseline), Post-dose (Up to 4 Years)Population: 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.
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.
Outcome measures
| Measure |
Axillary Hyperhidrosis
n=383 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale
Pre-dose (Baseline)
|
2.27 score on a scale
Standard Deviation 0.56
|
—
|
—
|
|
Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale
Change from Baseline at Post-dose
|
-1.53 score on a scale
Standard Deviation 0.54
|
—
|
—
|
Adverse Events
Axillary Hyperhidrosis
Focal Spasticity
Glabellar Lines
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER