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

Completed

• Conditions: Muscle Spasticity; Hyperhidrosis; Glabellar Lines
• Interventions: Biological: botulinum toxin Type A

• Registration Number: NCT02043145
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Status Verified: 2014-05
• Results First Submitted: 2014-05-15
• Results First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Results First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 727

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Axillary Hyperhidrosis	botulinum toxin Type A	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	botulinum toxin Type A	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	botulinum toxin Type A	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 Outcome Measures

Name	Time	Method
Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale	Pre-dose (Baseline), Post-dose (Up to 4 Years)	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.
Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)	4 Years	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.
Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale	Pre-dose (Baseline), Post-dose (Up to 4 Years)	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.
Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale	Pre-dose (Baseline), Post-dose (Up to 4 Years)	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.