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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02043145
Recruitment Status : Completed
First Posted : January 23, 2014
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment
Hyperhidrosis Muscle Spasticity Glabellar Lines Biological: botulinum toxin Type A

Study Design
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Study Type : Observational
Actual Enrollment : 727 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs) [ Time Frame: 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.

  2. Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale [ Time Frame: 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.

  3. Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale [ Time Frame: 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.

  4. Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale [ Time Frame: 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.


Eligibility Criteria
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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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043145


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02043145    
Other Study ID Numbers: EPI-MULT-100
First Posted: January 23, 2014    Key Record Dates
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Muscle Spasticity
Hyperhidrosis
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Sweat Gland Diseases
Skin Diseases
Botulinum Toxins
 Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents