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

This study is currently recruiting participants.
Verified March 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01686581
First received: September 13, 2012
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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®

  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 prescribed BOTOX® for the prophylaxis of headaches

Criteria

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 ClinicalTrials.gov identifier: NCT01686581

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
Germany
Recruiting
Kiel, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01686581     History of Changes
Other Study ID Numbers: MAF/AGN/NS/CM/002
Study First Received: September 13, 2012
Last Updated: March 13, 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

ClinicalTrials.gov processed this record on May 16, 2013