A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: December 12, 2012
Last updated: August 10, 2015
Last verified: August 2015
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.

Condition Intervention
Chronic Migraine, Headaches
Biological: onabotulinumtoxinA

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

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in the Number of Headache Days [ Time Frame: Treatment Cycle 7 (approximately 1.5 years) ] [ Designated as safety issue: No ]
    The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.

Enrollment: 33
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
Biological: onabotulinumtoxinA
Previous treatment with onabotulinumtoxinA for Chronic Migraine.
Other Names:
  • Botulinum Toxin Type A
  • BOTOX®


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who previously received at least 7 treatment cycles of onabotulinumtoxinA as Treatment for Chronic Migraine.

Inclusion Criteria:

  • 15 or more headache days over a 30 day period
  • A minimum of 7 treatment cycles with onabotulinumtoxinA

Exclusion Criteria:

  • Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
  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: NCT01749410

United States, California
Encinitas, California, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01749410     History of Changes
Other Study ID Numbers: GMA-BTX-CM-12-491
Study First Received: December 12, 2012
Results First Received: August 10, 2015
Last Updated: August 10, 2015
Health Authority: United States: Institutional Review Board

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 November 25, 2015