Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) in Korea

Muscle Spasticity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043145
• Other study ID #: EPI-MULT-100
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: May 15, 2014
• Start date: July 2008
• Est. completion date: April 2012

Study information

• Verified date: May 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 727
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glabellar Lines
• Hyperhidrosis
• Muscle Spasticity

Intervention

Biological:
• botulinum toxin Type A
Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 Years	No
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.	Pre-dose (Baseline), Post-dose (Up to 4 Years)	No
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.	Pre-dose (Baseline), Post-dose (Up to 4 Years)	No
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.	Pre-dose (Baseline), Post-dose (Up to 4 Years)	No