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Trial record 85 of 721 for:    Botulinum Toxins, Type A

A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine

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: NCT02147561
Recruitment Status : Completed
First Posted : May 26, 2014
Results First Posted : May 27, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.

Condition or disease Intervention/treatment Phase
Migraine Disorders Biological: botulinum toxin Type A Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Migraine

Arm Intervention/treatment
Experimental: botulinum toxin Type A
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Biological: botulinum toxin Type A
Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA




Primary Outcome Measures :
  1. Percentage of Patients With Adverse Events [ Time Frame: 28 Days ]
    An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.


Secondary Outcome Measures :
  1. Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score [ Time Frame: Baseline, Day 28 ]
    The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.

  2. Physician Global Assessment of Outcome on a 3-Point Scale [ Time Frame: Baseline, Day 28 ]
    Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ethnically Korean with a diagnosis of chronic migraine

Exclusion Criteria:

  • Anticipated need for botulinum toxin treatment for any reason other than chronic migraine during the study
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

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): NCT02147561


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

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02147561     History of Changes
Other Study ID Numbers: 191622-148
First Posted: May 26, 2014    Key Record Dates
Results First Posted: May 27, 2016
Last Update Posted: May 27, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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