An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine

This study is currently recruiting participants.
Verified November 2013 by Allergan
Information provided by (Responsible Party):
Allergan Identifier:
First received: September 13, 2012
Last updated: November 20, 2013
Last verified: November 2013

This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.

Condition Intervention Phase
Migraine Disorders
Drug: Onabotulinumtoxin A
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Healthcare Resource Utilization Using a Patient Questionnaire [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EuroQol Group EQ-5D Questionnaire Score [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Headache Frequency [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Patient Treatment Satisfaction Using a 4-Point Scale [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Migraine Specific Quality of Life Questionnaire (MSQ) Score [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: July 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Chronic Migraine Prescribed BOTOX®
Onabotulinumtoxin A (BOTOX®) administered according to physician prescription; all treatment decisions lie with the physician.
Drug: Onabotulinumtoxin A
Onabotulinumtoxin A (BOTOX®) administered according to physician prescription; all treatment decisions lie with the physician.
Other Name: BOTOX®


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 prescribed BOTOX® for the prophylaxis of headaches


Inclusion Criteria:

  • Prescribed BOTOX® for the prophylaxis of headaches

Exclusion Criteria:

  • Received treatment with any botulinum toxin Type A serotype in the last 26 weeks
  • Current participation in Allergan's Botox Chronic Migraine Post-Authorisation Safety Study (protocol 191622-110)
  Contacts and Locations
Please refer to this study by its identifier: NCT01686581

Contact: Allergan Inc.

Kiel, Germany
Oviedo, Spain
Stockholm, Sweden
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan Identifier: NCT01686581     History of Changes
Other Study ID Numbers: MAF/AGN/NS/CM/002
Study First Received: September 13, 2012
Last Updated: November 20, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014