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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01686581
First received: September 13, 2012
Last updated: October 29, 2014
Last verified: October 2014
  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:


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 ]

Enrollment: 645
Study Start Date: July 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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
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: NCT01686581

Locations
Germany
Kiel, Germany
Russian Federation
Moscow, Russian Federation
Spain
Oviedo, Spain
Sweden
Stockholm, Sweden
United Kingdom
Anlaby, Hull, East Yorkshire, United Kingdom
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: October 29, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 29, 2014