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BOTOX® Prophylaxis in Patients With Chronic Migraine

This study has been completed.
Information provided by (Responsible Party):
Allergan Identifier:
First received: September 9, 2011
Last updated: May 13, 2015
Last verified: May 2015
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 Intervention
Migraine Disorders
Biological: botulinum toxin Type A

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Incidence of Dysphagia [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Worsening or Intractable Migraine [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]

Enrollment: 1160
Study Start Date: September 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
botulinum toxin Type A
botulinum toxin Type A
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®


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

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01432379

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

Responsible Party: Allergan Identifier: NCT01432379     History of Changes
Other Study ID Numbers: 191622-110 
Study First Received: September 9, 2011
Last Updated: May 13, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
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 processed this record on December 06, 2016