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Trial record 91 of 720 for:    Botulinum Toxins, Type A

Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Chronic Migraine in Korea

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ClinicalTrials.gov Identifier: NCT01976611
Recruitment Status : Completed
First Posted : November 6, 2013
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.

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

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Study Type : Observational
Actual Enrollment : 402 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
BOTOX®
Patients who receive botulinum toxin Type A (BOTOX®) treatment for chronic migraine as per local standard of care in clinical practice.
Biological: botulinum toxin Type A
Botulinum toxin Type A treatment for chronic migraine as per local standard of care in clinical practice.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events and Adverse Drug Reactions [ Time Frame: 4 Years ]
  2. Headache Impact Test-6 (HIT-6) Score Using a 5-Point Scale [ Time Frame: 4 Years ]


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
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.
Criteria

Inclusion Criteria:

  • Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.

Exclusion Criteria:

  • None.

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): NCT01976611


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: NCT01976611     History of Changes
Other Study ID Numbers: 191622-139
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
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