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

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis; Muscle Spasticity; Glabellar Lines
• Intervention / Treatment: Biological: botulinum toxin Type A

• Study Type: Observational
• Enrollment (Actual): 727

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.

Description

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:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: botulinum toxin Type A; Botulinum toxin Type A (BOTOX®) 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.	Biological: botulinum toxin Type A; Botulinum toxin Type A (BOTOX®) 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.	Biological: botulinum toxin Type A; Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (ESTIMATE): January 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Sweat Gland Diseases; Skin Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Hyperhidrosis; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: EPI-MULT-100