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: February 18, 2016
Last verified: February 2016
  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: 644
Study Start Date: July 2015
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   (Adult, Senior)
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

  Show 76 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

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: February 18, 2016
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
OnabotulinumtoxinA
Botulinum Toxins, Type A
AbobotulinumtoxinA
IncobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 27, 2016