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BOTOX® Prophylaxis in Patients With Chronic Migraine

This study is currently recruiting participants.
Verified November 2012 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01432379
First received: September 9, 2011
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: April 2015
Estimated 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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432379

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

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

Additional Information:
More Information  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01432379     History of Changes
Other Study ID Numbers: 191622-110
Study First Received: September 9, 2011
Last Updated: November 28, 2012
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, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013