BOTOX® Prophylaxis in Patients With Chronic Migraine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01432379
First received: September 9, 2011
Last updated: May 21, 2014
Last verified: May 2014
  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:


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
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 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
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 ClinicalTrials.gov identifier: 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

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: May 21, 2014
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
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014