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BOTOX® Prophylaxis in Patients With Chronic Migraine

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ClinicalTrials.gov Identifier: NCT01432379
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.

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

Study Design

Study Type : Observational
Actual Enrollment : 1168 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2011
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Migraine
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
botulinum toxin Type A
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Biological: botulinum toxin Type A
155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
Other Name: BOTOX®


Outcome Measures

Primary Outcome Measures :
  1. Incidence Rate of Dysphagia [ Time Frame: 64 weeks ]
    Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.


Secondary Outcome Measures :
  1. Incidence Rate of Intractable Migraine [ Time Frame: 64 weeks ]
    Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Chronic Migraine
Criteria

Inclusion Criteria:

  • Diagnosis of chronic migraine
  • Willing to use BOTOX® as preventative treatment for migraine

Exclusion Criteria:

Contacts and Locations

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): NCT01432379


Locations
Germany
Munich, Germany
Spain
Oviedo, Spain
Sweden
Stockholm, Sweden
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01432379     History of Changes
Other Study ID Numbers: 191622-110
First Posted: September 13, 2011    Key Record Dates
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016
Last Verified: October 2016

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